Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says

After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. 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 drug maker 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 M. Azar II, 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, Mr. 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.