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Guest Opinion: The Biden Administration is "Marching In" On Innovation

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By John S. Sears

What do the HIV drug Emtricitabine, next-generation navigation gyroscopes for autonomous cars, and unmanned air vehicles have in common?

All three were developed at prestigious research universities -- and were created in part using basic scientific research funded by the U.S. government.

All three are also examples of technology success stories that could be threatened if the Biden administration's proposed changes to federal research licensing go into effect.

Last year, the National Institute of Standards and Technology (NIST) published a proposal that, for the first time, would allow the federal government to "march in" and rescind patent protections for commercial products developed with federal dollars when the government deems those products too expensive.

Understanding the significance of this decision requires looking back to the Bayh-Dole Act of 1980. Prior to Bayh-Dole, the United States had established itself as a research powerhouse. But while the U.S. government had accumulated more than 28,000 patents, it had licensed less than 5% of them for commercial development.

Bayh-Dole changed that by allowing small businesses and universities to retain patent rights on inventions developed with the help of federal funding. Studies have found that, in the four decades since its inception, Bayh-Dole has generated $1.9 trillion in U.S. economic growth, supported 6.5 million jobs, and spawned over 17,000 startup companies.

Bayh-Dole gives the federal government the ability to "march in" and relicense these patented technologies to third parties under certain conditions. But in more than 40 years since Bayh-Dole's inception, there has never been a single occurrence of a federal agency exercising march-in rights. It has historically been understood as a form of recourse appropriate only in exceptional circumstances. And the authors of Bayh-Dole explicitly stated that price is not a legitimate basis for march-in.

Across all industries, Bayh-Dole has been a huge success because it balances the risks and incentives between public funding of early-stage research and the private sector's R&D efforts. This has fueled research and development across all industries -- and generated billions in private-sector capital investment to support the licensing and commercialization of federally sponsored technologies.

If, under the proposed framework, companies and investors must contend with federal agencies relicensing their technologies based solely on price, investors may simply decide that the risks of investing in federally backed research outweigh the rewards -- and shift their investments to technologies that are not funded by federal dollars.

If that happens, it will take us back to the stagnant, pre-1980s era of commercialization of federally funded research. It would also undermine technologies developed through the CHIPS Act, among many other federal programs.

Earlier this year, a bipartisan group of 28 lawmakers sent a letter to President Biden to express their concerns with the proposal. We can only hope the White House listens.

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John S. Sears is an IAM 300 top global intellectual property strategist recognized for his work with early-stage companies and technologies. He is a Senior Partner at the law firm Johnson, Marcou, Isaacs, & Nix and a Principal at venture capital firm Anzu Partners. He holds a PhD in chemistry from Georgia Tech and a law degree from Wake Forest University School of Law. This piece first appeared in the Atlanta Journal-Constitution.

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