Truvada can almost entirely prevent the transmission of HIV, though Gilead, which claims an exclusive patent on the drug, has set the price so high that it’s unaffordable to many.
But a new review of patent information reveals the company’s claim of exclusivity may not be accurate. Working with experts at Yale Law School, researchers with the advocacy group Prep4All dug through patent records, seeking evidence that Gilead does indeed have exclusive rights to manufacture the drug. What they found, however, is that Gilead never applied for exclusivity in the United States.
Truvada was developed with extensive support from the Centers for Disease Control (CDC), advocates say, and they argue the patent should be publicly held. If the company was found to have been improperly asserting a patent on the drug, it could owe royalties of around $1 billion, according to the Financial Times.
During a hearing this year, Gilead CEO Daniel Day claimed, “Gilead invented Truvada. No one else.”
That contrasts with remarks from Dr. Robert Grant, who told lawmakers that Gilead “did not provide leadership, innovation or funding for PrEP research.” Grant has been a key PrEP and PEP researcher for nearly 20 years.
The Department of Justice (DOJ) is currently investigating patent ownership. But lawmakers have expressed concern federal authorities might be unduly influenced by a recently announced partnership between Gilead and the Trump administration. The company claimed earlier this year it would donate 2.4 million bottles of Truvada in a deal brokered with the Department of Health and Human Services (HHS).
Instead of donations, HIV advocates have been calling for an overall decrease in the cost of treatment. When it launched in 2004, Truvada cost $800 per month; today it’s nearly $2,000 per month.
In particular, experts say generic versions are urgently needed. In Australia, generic Truvada pills cost just $8 per month.
With the high costs of the drug in the U.S., less than 10 percent of the people who could benefit most from PrEP are currently using it, according to the online mapping tool AIDSVu. In addition to the price tag, insufficient education of both doctors and patients presents additional barriers to access.
It’s unclear why the CDC has not pursued what many experts say is a legitimate claim on a patent for the drug. At an AIDSWatch meeting last April, advocates from Prep4All confronted CDC Director Robert Redfield to demand better enforcement of publicly owned patents.
So far, action from the CDC has not been forthcoming. At a hearing in Washington, D.C., O’Day said generic versions of Truvada will become available in the U.S. next year.
Meanwhile, Gilead is preparing to roll out a new drug known as Descovy, which early research indicates presents fewer side effects than Truvada. But Gilead has so far limited most trials to patients assigned at birth as male, so its efficacy remains in question.