WASHINGTON, D.C.—Last year Gilead Sciences, the pharmaceutical company that produces HIV PrEP drugs Truvada and the new Descovy, made $3 billion in sales of Truvada. That's pretty good coin for selling a drug it didn't have to spend a dime to research.
That research was in fact done by scientists at the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention, which patented the generic formula for Truvada in 2015, and which stated in a press release yesterday that Gilead had "willfully and deliberatively induced infringement of the HHS patents," and the U.S. Department of Justice filed suit against Gilead for patent infringement yesterday.
As The Washington Post's Christopher Rowland pointed out last March, "The Department of Health and Human Services, which includes the CDC and the National Institutes of Health, has patented more than 2,500 inventions created with taxpayer dollars since 1976, according to the U.S. Patent and Trademark Office. It routinely licenses new pharmaceutical compounds to private companies that take those publicly financed discoveries into the marketplace."
One problem, though: No matter how much money those private companies make from the CDC's inventions, the government rarely sees any royalties from those sales, and while those private drug manufacturers often sue each other for patent infringements and the like, the government itself rarely brings such legal actions—and some scientists have become a bit upset over that.
"The CDC has all these patents and is allowing Gilead to rip off the American people at the expense of public health," charged HIV/AIDS activist James Krellenstein, co-founder of the PrEP4All Collaboration, who has spent months digging into the government patents, and had charged CDC officials with "twiddling their thumbs" over their lack of legal action against Gilead.
Part of the reason Krellenstein and others are so upset is that a year's supply of Truvada cost as much as $20,000, depending on insurance coverage—until Gilead announced that it was donating 200,000 doses of Truvada per year to HHS. This might seem generous were it not for a couple of facts: 1) generic versions of the drug produced in India clock in at $60 per year; and 2) 200K doses is a flash in the pan compared to the fact that in 2016, federal officials estimated that less than 10 percent of the 1.1 million people wo should be on PrEP were actually receiving the drug; and 3) Gilead's new PrEP drug Descovy was recently approved for sale, and that's what Gilead is concentrating its marketing efforts on today.
Also in the mix: California Gov. Gavin Newsom signed into law SB 159 on October 7, which will allow PrEP drugs like Truvada to be sold over the counter at pharmacies without the need of a prescription—a development which could lead to a large decrease in the cost of PrEP... but has yet to do so.
"For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this life-saving medication, despite it being a taxpayer-funded invention," charged PrEP4All, a group that has pushed for wider access to the drug. “If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it."
Gilead's defense to these charges, according to The Post, has been that "independent researchers had already discussed the idea of using Truvada to prevent HIV by the time CDC applied for its patent," but a commenter to The Post's article claimed that, "If Gilead says 'independent researchers' had already discussed PrEP, they must mean the researchers over in Europe—not the United States. That mid-2000's conference involved Swiss or Swedish researchers working for their government health authority. Just look up the medical journals for any reports from the major conferences on infectious diseases/HIV back in the mid-2000's. European researchers stunned the conference by describing treatment's effect on population-based seroprevalence—actual evidence, not some scenario kicking around or a proof-of-concept."
In any case, Gilead has earned $36.2 billion on Truvada since 2004, according to its annual reports.
