Drugmaker slammed with federal lawsuit over HIV patent

After years of prodding by patient advocates, federal officials on Wednesday sued the drugmaker Gilead Sciences, charging that it had infringed government patents on the idea of preventing HIV with a daily pill.

The suit, by the Department of Health and Human Services, came as a pleasant shock to many critics of the company, including Democratic members of Congress who had pressed the administration to act.

It is very rare for the government to take on a drugmaker over patents. But the medications made by Gilead are necessary to end the AIDS epidemic by 2030, which the Trump administration has set as a goal. That cannot be accomplished if the drugs are not made more affordable.

Still, exactly what effect the lawsuit will have in the fight against AIDS remains unclear.

Certainly, it was an unexpected turnabout by Alex Azar, the secretary of health and human services.

In May, he had praised Gilead for donating Truvada to the administration’s campaign to beat the AIDS epidemic.

On Wednesday, Azar struck a much harsher tone. “Gilead must respect the U.S. patent system, the groundbreaking work by researchers with the Centers for Disease Control and Prevention, and the substantial taxpayer contributions to the development of these drugs,” he said in a prepared statement.

The lawsuit bluntly accused Gilead of exaggerating its role in developing pre-exposure prophylaxis, or PrEP, ignoring work by government scientists and “baselessly denying” the validity of federal patents.

“The fact that the federal government sued a drugmaker over a medication developed in part with taxpayer money is a milestone,” said Zain Rizvi, a researcher in the medicines access program at the advocacy organization Public Citizen.

Gilead has responded that the government patents are invalid and denied infringing them.

The government first applied for patents on prophylaxis techniques in 2006. Gilead recently asked the Patent and Trademark Office to cancel the government patents, arguing that other researchers already had conceived the idea of using drugs to prevent HIV.

Gilead said it would ask the court to stay the government’s suit until the patent office reaches a decision.

PrEP is a drug regimen: A person at risk of contracting HIV is prescribed one of two drugs to be taken in pill form once daily to prevent the infection. Both of the drugs approved for use in this regimen, Truvada and Descovy, are made by Gilead.

If taken daily, the drugs cut the risk of HIV infection by more than 99 percent.

About 1 million Americans are at high risk of getting HIV through sex or shared needles and would benefit from PrEP, according to the CDC. But just 270,000 Americans are on PrEP, and there are about 40,000 new infections each year.

The price has been an obstacle, critics say. Truvada, which will come off patent next year, has cost about $20,000 per patient per year in recent years; Descovy currently costs about the same. In other countries, generic versions of Truvada sell for as little as $60 a year.