100 experts urge HHS to reject Bayh-Dole ‘march-in’ petition

researchers working in a lab

A recent letter to U.S. Health and Human Services Secretary Xavier Becerra explains why a petition asking the government to “march in” on a prostate cancer drug under the Bayh-Dole Act should be rejected.

“The purpose of the Bayh-Dole Act was not to create a mechanism for the federal government to set prices on successfully commercialized products,” says the letter to Secretary Becerra, signed by nearly 100 academic and private-sector innovation experts and organizations, legal scholars, and policy organizations (including the Biotechnology Innovation Organization).

What is the Bayh-Dole Act?

The bipartisan Patent and Trademark Law Amendments Act empowers universities, small businesses, and non-profits to own and license inventions made with federally funded research—to turn basic research into tested and approved products.

“Bayh-Dole has spurred 13,000 startups, resulted in more than 100,000 new patents, and led to the disclosure of more than 420,000 inventions just from 1996-2017,” reported Bloomberg Law—as well as some 300 drugs on the market.

The law does allow the government to “march in” and force additional licenses under limited circumstances—but not because “someone doesn’t like the price of a resulting product,” Bayh-Dole Coalition Executive Director Joe Allen explains in a recent piece for IPWatchdog. March-in petitions based on price have previously been rejected by both Democratic and Republican administrations.

A ‘flagrant’ misrepresentation of the law

But a recent petition asks NIH to “force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost,” says Allen—even though previous petitions based on price for this very drug have been rejected.

“The petition flagrantly misrepresents the meaning of the Bayh-Dole Act,” said Allen in a statement about the letter. “The Act’s purpose is to facilitate the commercialization of technologies developed from federally funded inventions—not to serve as a backdoor for price controls of successfully developed inventions.”

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