Commentary

HSS Sues Gilead Sciences Over Patents For HIV Prevention Drugs

In a lawsuit filed yesterday, the U.S. Department of Health and Human Services accused the pharmaceutical firm Gilead Sciences of infringing on government patents in its marketing of Truvada and Descovy, two pricey drugs it has developed that prevent the spread of HIV.

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The filing in U.S. District Court for the District of Delaware “[escalates] a fight that has been brewing for months,” Dani Kass writes  for Law360. “HHS said it has repeatedly tried to license its patents for pre-exposure prophylaxis, or PrEP, but that Gilead has rebuked those attempts. The agency faults Gilead for making billions off its sales of the PrEP medications Truvada and Descovy, based on innovations funded by taxpayers.”

“Truvada for PrEP can set a patient back about $2,000 for a 30-day supply. Its accessibility is key to fulfilling the president’s promise to eradicate HIV and AIDS by 2030. Truvada and Descovy are the only two drugs approved to prevent HIV. The high cost of the drugs, along with Gilead's sizable profits from making them, have led some congressional Democrats to demand that the administration look into whether the company is infringing on government patents,” Cassidy Morrison writes for the Washington Examiner.

In a contentious House Oversight and Reform Committee hearing last May, its late chairman Elijah Cummings asked, “How can Gilead do this? How can our system allow a company to take a drug treatment that was developed with taxpayer funds and abuse its monopoly to charge such astronomical prices? This lifesaving treatment would not exist but for the research funded by the CDC and the NIH,” Emily Kopp reports  for Roll Call.

In the news release announcing  yesterday’s action, HHS points out that “since the beginning of the AIDS epidemic in the early 1980s, researchers worldwide sought drug-based strategies to effectively prevent the spread of HIV. For over two decades, none succeeded. During that time, over 25 million people died due to AIDS. And the number of people living with HIV reached its highest level -- about 40.3 million people. 

“In the mid-2000s, researchers at the CDC succeeded where others had not. These scientists developed innovative two-drug regimens to effectively prevent HIV infection. This type of regimen is known as PrEP,” HHS continues.

“HHS recognizes Gilead's role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” HHS Secretary Alex M. Azar II says in a statement. “However, Gilead must respect the U.S. patent system, the groundbreaking work by [Centers for Disease Control and Prevention] researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do."

“The action follows an article  in March in The Washington Post that described the standoff between Gilead and the CDC and the National Institutes of Health over the patent for Truvada for PrEP. The Post reported on frustration among activists and researchers that the government had not taken legal action in the face of Gilead’s defiance, despite having won its patents in 2015,” writes  The Post's Christopher Rowland. 

“In April, The Post reported that the Department of Justice had opened a review of the patent. Gilead has disputed the government’s patents, filing a formal challenge to the patents in August. Gilead did not respond to a request for comment Wednesday night,” Rowland continues.

“Wider access to PrEP is central to the government’s goal, announced in February, to reduce new HIV infections by 75% over five years, and to ‘end the HIV epidemic in America’ by 2030. Critics have said the drug’s lofty price tag has limited its accessibility to high-risk people with low incomes, thwarting the government’s efforts,” Daniel Victor writes  for The New York Times, adding that Gilead makes more than $3 billion a year on Truvada.

“In May, Gilead said it would donate enough medication to supply 200,000 patients with the drug for up to 11 years. But about 1 million Americans are estimated to be at risk for infection, and only about 270,000 people take the pills,” Victor adds.

The battle over pricing drugs that have been developed, at least in part, through government funding has a long history. 

“If only our elected officials would take a look at existing laws on the books, they might notice that one already holds the potential to make pharmaceuticals significantly more affordable for all Americans and to reduce the inflated costs for these proposed subsidies. It is called the Bayh-Dole Act.” professors Peter Arno and Michael Davis wrote in an opinion piece published in The Washington Post in 2002. “Unfortunately, no one is enforcing it.”

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