Gilead Science’s claim of patent exclusivity on Truvada for PrEP is coming under fire, after researchers suggested the company’s assertion may not be accurate.
Gilead launched Truvada in 2004 to treat patients suffering from HIV/AIDS. In 2012, Truvada became the first medication ever approved by the U.S. Food & Drug Administration (FDA) for HIV prevention, or pre-exposure prophylaxis (PrEP).
While Truvada for PrEP could virtually eradicate HIV, it is prohibitively expensive in the United States (around $20,000/year) due to Gilead’s claim of patent exclusivity. As a result, just 10% of Americans who could benefit from the drug are able to actually obtain Truvada.
Patient advocates in the United States insist that generic equivalents are desperately needed, but they won’t become available until Gilead’s Truvada patents expire. In Australia, were generic equivalents have already hit the market, Truvada for PrEP cost just $8 per month.
These same advocates have long disputed Gilead’s claim of patent exclusivity, pointing out that Truvada for PrEP was developed with extensive support from the U.S. Centers for Disease Control (CDC). As such, they argue that the patent should be held publicly.
Earlier this year, The Washington Post reported that the CDC had never enforced its own patents for Truvada. Gilead claims these patents are invalid, but the report prompted the U.S. Department of Justice to open an investigation. Not long after, Gilead struck a deal with the Trump administration to donate 2.4 million bottles of Truvada, raising concern that the company was attempting to influence the probe.
According to a new report from The Financial Times, experts at Yale University and researchers with Prep4All recently concluded a search of patent records and found that Gilead never actually applied for patent exclusivity on Truvada for PrEP.
“Truvada was not granted any exclusivity specific to PrEP by the FDA that was in effect between 2012 and now. That absence of exclusivity meant and means one fewer obstacle for generics to come into the market,” Christopher Morten, a staff attorney and lecturer at Yale Law School, told The Financial Times.
If these findings are valid, Gilead could end up owing the federal government as much as $1 billion in Truvada royalties.
While Gilead acknowledges never seeking exclusivity on Truvada for PrEP, the company maintains that “the patents listed in the Orange Book for Truvada cover all uses of the product, including for treatment for HIV [and two types of prophylaxis, including PrEP].”
This isn’t the first time that Gilead has faced questions over the handling of its HIV drug patents.
In fact, the drug maker is currently defending a growing number of lawsuits filed on behalf of individuals who claim Gilead intentionally delayed development of a safer HIV medication called TAF merely to protect the profits derived from its patents for Truvada and other TDF-based HIV treatments.
The majority of those claims are currently undergoing coordinated judicial proceedings in the San Francisco Superior Court. (Gilead Tenofovir Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 5043.)