Policy and Legal

The Biden administration’s push to invoke “march-in” rights is unlawful and would have “disastrous consequences” for the United States if enacted, the NAM told the Senate Tuesday.

What’s going on: Ahead of a Senate Judiciary Committee hearing on intellectual property in the biopharmaceutical sector, the NAM warned of the potentially dire consequences of the proposed march-in framework issued by the National Institute of Standards and Technology.

• The NIST proposal would allow the federal government to “march in” and seize manufacturers’ patent rights if an innovation was developed in any part with federal dollars.
• In the biopharmaceutical sector and other innovative industries, federal funding plays an important role in supporting early-stage research—but further R&D, product development and commercialization require hundreds of millions to billions of dollars in additional capital from investors and established companies.
• Robust IP protections ensure that manufacturers can bring innovative products to consumers.

Why it’s a problem: March-in would violate manufacturers’ IP rights and prevent investment into lifesaving and life-changing technologies, according to NAM Vice President of Domestic Policy Charles Crain.

• “Allowing march-in based on the price of a product or technology, as the NIST guidance proposes … would undermine manufacturers’ IP rights and have sweeping ramifications for innovation in the United States and America’s world-leading innovation economy,” Crain told the committee.
• Committee member Sen. Chris Coons (D-DE) agreed during the hearing that the proposal is fundamentally flawed. “Any company [that] invents [anything] or any researcher who invents anything is now open to the federal government saying, ‘I want that, and I don’t agree with the price you’re setting for it,’” he said.

What should happen: Congress must stop NIST’s overreach, Crain said.

• “Policies that threaten IP protections, like NIST’s proposed march-in guidance, will cede one of our greatest advantages to our competitors. Manufacturers [look forward] to work[ing] with the committee to ensure the U.S. maintains the strongest IP protections in the world in order to spur the discovery and commercialization of inventions that improve health and quality of life for all people.”