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26 April 2022Big PharmaAlex Baldwin

Warren: Biden must ‘break patent barriers’ to drive down drug costs

Senator Elizabeth Warren has urged the US Department of Health and Human Services (HHS) to “break patent barriers” in order to foster competition to lower prescription drug prices.

Warren’s letter, addressed to HHS Secretary Xavier Becerra, outlines three “legal tools” suggested by more than 25 “legal and public health experts” that the Biden Administration can use to “swiftly” lower drug prices for consumers.

Alongside this letter, she also published the letter addressed to her by the 25 experts, which was led by alumni from Yale Law School, Harvard Medical School, and Columbia Law School.

“High prescription drug prices in the United States are a major problem today for both patients and the sustainability of our healthcare system… Existing law gives the executive branch several tools to intervene when patients and public health are harmed by excessive drug prices.

“These tools can help the Administration break patent barriers, foster competition where currently there is none, and drive down prices. Critically, using them requires no additional congressional action,” wrote the legal and public health experts.

The letter suggests that the Biden administration utilises the “government patent power” codified in 28 USC section 1498 and the Bayh-Dole Act’s “royalty free-licence” and “march-in rights”.

Warren suggests that these three tools are “integral, longstanding, and legitimate parts of our patent system”.

The experts claimed that section 1498 serves as a “powerful general-purpose tool to target excessive pricing” while the “Bayh-Dole Act is particularly helpful for patents that received government research support”.

“We believe that the two can and should be used together as part of cohesive strategies when drugs of high public health importance are sold to US patients at excessive prices,” the letter said.

Co-signers of the expert letter include Amy Kapczynski at Yale Law School, Aaron Kesselheim at Harvard Medical School, and Christopher Morten at Columbia Law School.

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Americas
22 February 2022   US Senator Elizabeth Warren has urged the Department of Health and Human Services (HHS) to seize control of patents covering Pfizer’s prostate cancer drug Xtandi (enzalutamide).
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23 May 2021   The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.