March-in rights under the Bayh–Dole Act undermine the US drug development sector without lowering drug costs

Subjects

The authors of a recent Feature article, “The strength and importance of government-funded patents for approved drugs”¹, inaccurately suggest that the Bayh–Dole Act empowers the US federal government to “march in” on “drugs with key government-funded patents made available at high prices.” As the executive director of the Bayh–Dole Coalition and a former Senate staffer who helped to draft and enact that law, I feel compelled to rebut that claim. Every administration that has reviewed march-in petitions — including the Biden and Obama administrations — concluded that the Bayh–Dole Act does not permit the government to march in and relicense patents solely based on the price of commercially available products.

The authors also overstate the government’s role in drug development. Although government funding is important, it is dwarfed by industry expenditures. One study found that for therapies approved by the Food and Drug Administration from 2011 to 2020 that benefited from federal funding, industry had invested $44.3 billion versus $276 million by the government².

This is a preview of subscription content, access via your institution