Stabenow, Cummings Call for Government Accountability Office Review of Potential Patent Infringement by Gilead Pharmaceuticals

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Stabenow, Cummings Call for Government Accountability Office Review of Potential Patent Infringement by Gilead Pharmaceuticals

The following press release was published by the House Committee on Oversight and Reform on June 18, 2019. It is reproduced in full below.

WASHINGTON, D.C. - U.S. Senator Debbie Stabenow (D-MI), Ranking Member of the Health Subcommittee of the Senate Finance Committee, and U.S. Congressman Elijah Cummings (D-MD), Chairman of the House Oversight and Reform Committee, today called for a Government Accountability Office review of how the Department of Health and Human Services (HHS) prevents pharmaceutical companies from infringing on government-owned patents. They also called for a review of how HHS could use the process of licensing government-held patents to improve drug access and affordability.

The lawmakers previously submitted separate requests to HHS seeking documents and information about patents relevant to Gilead Sciences’ HIV-prevention drug, Truvada, which was approved for PrEP based on taxpayer-funded research and government patents, but is unaffordable for most Americans.

“Numerous reports have suggested that Gilead Sciences may be infringing on several patents held by the United States of America through the Centers for Disease Control and Prevention, which are relevant to the use of Gilead’s drug Truvada for pre-exposure prophylaxis (PrEP)," the lawmakers wrote. “If true, this would mean that a private entity has generated billions of dollars in revenue over several years while infringing on government-owned intellectual property, and that the government either failed to detect the infringement or was aware but failed to prevent it."

“We are requesting that you conduct a review of the steps that HHS takes to detect and prevent the infringement of intellectual property owned by the United States to ensure that any private enterprises that make use of government-owned intellectual property properly compensate the government," the lawmakers continued. “We would also like you to assess whether and how HHS considers the impact of prescription drug prices and affordability when granting exclusive licenses to pharmaceutical companies."

A PDF of the letter may be found here.

Source: House Committee on Oversight and Reform

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