August 6, 2020
CASE today issued a strong rebuke to a letter signed by more than two dozen state attorneys general seeking to have the Federal Drug Administration (FDA) and Department of Health and Human Services (HHS) use the Bayh-Dole Act to grant march-in rights for states to license the production of the promising Covid treatment remdesivir. The letter falsely accuses the drug’s maker, Gilead Science, of not doing enough to make the drug accessible to the public, and of setting an unreasonable price, two accusations that stray far from facts while promoting an unlawful misapplication of the Bayh-Dole Act.
Said CASE co-founder Gerard Scimeca, “This effort is a direct assault on the very medical innovations that America and the world are counting on to help us defeat the coronavirus, and further undermines the process by which drug makers are able to make these critical medications available to the public in the midst of a public health crisis. Politicians with no experience in developing a drug or bringing it to market should not be allowed to disregard facts, misapply the law, and bully innovators into relinquishing their intellectual property rights merely to score headlines during an election year.”
Bayh-Dole gives the federal government march-in rights to seize inventions produced with government funds if the current patent holder is not making the invention readily available to the public, or when public health is at risk through inaction. None of these conditions reflect Gilead’s efforts with regard to remdesivir, a drug which has been used for more than a decade to treat several virus outbreaks, and which was created through private research funding. Further, Gilead is producing several million treatments of the drug this year and will continue to add production in 2021, far more treatments than will be needed given the narrow base of Covid sufferers for whom the drug is appropriate.
“HHS has rightfully responded to this ludicrous request by acknowledging that march-in rights are wholly inapplicable to remdesivir as it was not created with government funding but through privately funded research,” added Scimeca. “It is surprising and fairly disturbing that elected officials whose job it is to uphold the law would seek to use the power of the federal government to strip ownership rights from a private company under entirely false pretenses. Not only do these politicians misapply the Bayh-Dole Act, but they do so while misrepresenting the available supply being produced for patients in need, as well as the drug’s use in hospitals which is playing an enormous role in lowering costs of Covid treatments for patients that would otherwise have few or no options.
“The bottom line is that U.S. consumers don’t need activist politicians robbing the storehouse of innovation that will produce the medical cures of the future, especially at a time when drug makers like Gilead are making enormous contributions to our battle against Covid-19. Bayh-Dole was never intended to facilitate government theft, which is exactly what this letter advocates through an entirely inappropriate and unlawful use of Bayh-Dole based on non-existent facts. This political gesture must be summarily dismissed by the FDA and HHS in the strongest of terms.”
