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The Bayh-Dole Act plays “a critical role in biopharmaceutical innovation and commercialization” and must be maintained, along with the current flat fee for patent registration and maintenance, the NAM reminded Congress recently.

What’s going on: Bringing new, lifesaving treatments and cures to market entails a “cycle of discovery and development [that] makes biopharmaceutical manufacturers economic engines,” the NAM told the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence and the Internet last week ahead of its hearing on medical innovation and intellectual property.

• “To fulfill this role, manufacturers require a stable, pro-growth policy environment that includes protection of the Bayh-Dole Act and other aspects of the U.S. IP system that enable technology transfers.”
• Bayh-Dole allows private-sector entities to own, license and commercialize patents for inventions that were developed from some amount of federally funded research.

The concern: Some recent proposals to allow the federal government “to seize patent rights licensed by manufacturers from federally funded research institutions, unless the licensees abided by arbitrary price controls,” would violate Bayh-Dole, the NAM said.

• The NAM has long advocated against allowing such “march-in” rights and was instrumental in the administration’s decision not to finalize the previous administration’s draft guidance on the practice. (Manufacturers strongly urge the administration to rescind the guidance permanently.)
• The NAM also opposes “any proposal to impose a tax on the royalties that universities earn from licensing patented discoveries made with federal grants,” which would “weaken technology transfers … by leading federally funded research institutions to scale back their efforts to license their inventions.”

Maintain the current fee system: Manufacturers also urged legislators to maintain the current flat fee system for patent registration and maintenance.

• Some proposals have advocated replacing the current structure with a percentage-based charge on a patent’s assessed value.
• However, “[s]uch a tax on innovation and its commercialization would disrupt efforts to maintain and strengthen America’s global technological and scientific leadership.”

The last word: Congress must “ensure that the U.S. IP system continues to incentivize innovation and technology transfers so America remains the leader in biopharmaceutical innovation,” said NAM Senior Director of Technology Policy Franck Journoud, NAM Director of Health Care Policy Jess Wysocky and NAM Vice President of Domestic Policy Jake Kuhns.