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Gilead CEO insists government patent for HIV prevention pill Truvada is invalid

libadmin May 16, 2019

Daniel O’Day, CEO of Gilead Sciences, right, and patient advocate Aaron Lord are sworn in before the House Oversight and Reform Committee during a hearing on Thursday. (Bill O’Leary/The Washington Post)

May 16 at 10:39 AM

The chief executive of Gilead Sciences, the nation’s leading manufacturer of HIV drugs, insisted before a House committee Thursday that a government patent on Truvada, a key drug that prevents the infection, is invalid.

“Our well-supported view is that the U.S. government does not hold valid patents on the use of Truvada for pre-exposure prophylaxis (‘PrEP’), nor does it hold any patent for Truvada itself,’’ Daniel O’Day said in prepared testimony before the House Oversight and Reform Committee.

The panel called the hearing afterThe Washington Post reported in March that the government had opted not to file an infringement suit to enforce a 2015 patent on Truvada from the Centers for Disease Control and Prevention. The use of the drug to prevent HIV infection was discovered in federal labs in Atlanta, according to the government.

Since the article appeared, members of Congress have written letters to the Department of Health and Human Services demanding to know why the patent has not been enforced. The Justice Department has opened a review of the patent, which would be an initial step toward more aggressive enforcement.

HIV/AIDS activists who have been reviewing Gilead’s patents for Truvada unearthed the CDC patent last year. The Oversight Committee did not invite any government officials to its hearing Thursday.

Oversight Committee Chairman Elijah E. Cummings questions Daniel O’Day during a committee hearing on Thursday. (Bill O’Leary/The Washington Post)

“This treatment was developed as a result of investment made by the American taxpayers. The problem is that Gilead, the company that now sells the drug, charges astronomical prices,’’ said Oversight Chairman Elijah E. Cummings (D-Md.). Gilead charged $800 a month for the drug when it was introduced in 2004. The drug now costs $2,000 a month, Cummings said.

“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?’’ he said as the hearing opened Thursday.

Cummings credited Rep. Alexandria Ocasio-Cortez (D-N.Y.) for pushing the issue and calling for a hearing to question Gilead executives.

Rep. Jim Jordan (Ohio), the ranking Republican on the committee, accused the Democratic majority of “demonizing’’ Gilead and applauded the company for its innovative work.

O’Day, in his prepared testimony released Thursday morning by the committee, cited Gilead’s recent agreement with the Department of Health and Human Services to distribute enough free Truvada to treat 200,000 people a year. That is the equivalent of 2.4 million bottles of pills.

Truvada has earned Gilead about $3 billion a year, but it is about to lose its exclusive patent protection. Generics will be available beginning in 2020 and are expected to gut that revenue. O’Day cited Gilead’s efforts to help the government meet President Trump’s goal of eradicating AIDS by the end of the next decade.

“All of us at Gilead are proud to join with the government in our collective national effort to end HIV in the United States by 2030,’’ he said in his prepared remarks. “Gilead’s donation to this effort is among the largest pharmaceutical donations ever in U.S. history.”


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