TechPat: Justice Department Reviews Truvada Manufacturer for Possible Patent Violations

The U.S. Department of Justice (DOJ) has recently opened an investigation into possible violations of Gilead Sciences, Inc.’s exclusive license with the U.S. Government of its blockbuster HIV drug, TRUVADA®.  Truvada is the pre-exposure prophylaxis (PrEP) which has been shown to prevent HIV infections.  Because of its exclusive license, Gilead is the only manufacturer of the PrEP drug and a 30-day supply costs users between $1,600 and $2,000.  Critics have argued that this extreme price, which has given Gilead $3 billion in sales in 2018, allows Gilead near-anti-trust rights over the only drug shown to prevent HIV.  Further, Gilead has argued that the government’s Truvada patents are invalid, even though the same patents were researched and procured through the U.S. Department of Health & Human Services (HHS) at a cost to the taxpayers, and as a result, justifies Gilead’s refusal to accept any royalty deal in the profits from Truvada.

These patents are:

• U.S. Patent No. 9,044,509 (‘509), issued February 28, 2017;
• U.S. Patent No. 9,579,333 (‘333), issued February 29, 2017;
• U.S. Patent No. 9,937,191 (‘191), issued April 10, 2018.

There is one pending patent application:

• U.S. Patent Application Publication No. 2018-0193366 (‘366), published July 12, 2018.

All of the issued patents and pending application were filed with the HHS as the applicant/assignee.

All are entitled “Inhibitions of HIV infection through chemoprophylaxis.”  The claims of the patents are directed to methods for administering tenofovir disoproxil fumarate (the active ingredient of Truvada) for HIV (‘509), method for dosing administration of tenofovir disoproxil fumarate to treat HIV (‘333), and method for dosing administration of tenofovoir disoproxil fumarate in combination with emtricitabine (‘191).  Provisional claims are further directed to dosing administration of tenofovir disoproxil fumarate and emtricitabine (‘366).

The opening of the review comes on the heels of the DOJ dropping its False Claims Act case against Gilead, brought by former employees who alleged Gilead misrepresented the sourcing of the active ingredient entricitabine of its three HIV drugs – Emtriva, Truvada, and Atripla – from the Food & Drug Administration (FDA).  The district court dismissed the case, but was reversed by the Ninth Circuit Court of Appeals (with rehearing denied).  Gilead’s petition for writ of certiorari (with the DOJ filing an amicus curiae brief on behalf of the respondents) was denied by the U.S. Supreme Court in January 2019, allowing the case to proceed to trial on the merits back at the district court.

Because of its impact on millions of people, we will continue to monitor developments on the royalty negotiations and report back on the blog.