New Bayh-Dole Act rule clarifies procedures and removes outdated references
Bayh-Dole allows the government to assert march-in rights under prescribed circumstances, such as if the patent owner is not taking steps to achieve practical application of the invention or is not reasonably satisfying regulatory requirements for public use.
The State Science and Technology Institute reports in its latest SSTI Digest that the National Institute of Standards and Technology (NIST) published the revised Bayh-Dole Act rule, “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions,” clarifying procedures and removing outdated references.
According to the analysis, revisions were made in response to more than 80,000 comments received in response to a notice of proposed rulemaking issued in January 2021. An earlier proposed change that would have codified the long-held policy that march-in rights — those granted to the federal government in specified circumstances allowing it to grant patent licenses to parties other than the patent owner if the research and development is federally funded — cannot be exercised solely on the basis of product pricing is not included in the revisions.
The Department of Commerce and the Department of Health and Human Services will convene a working group of diverse stakeholders — federal agencies, patient groups, tech transfer organizations, industry, and investors — to consider further clarifications to the rule, in particular, whether perceived high product pricing may be grounds to exercise march-in rights.
Bayh-Dole allows the government to assert march-in rights under prescribed circumstances, such as if the patent owner is not taking steps to achieve practical application of the invention, is not reasonably satisfying health or safety needs, or is not reasonably satisfying regulatory requirements for public use. The idea is to strike a balance between incentivizing the commercialization of federally funded research and ensuring public access to those products.