Bayh-Dole Act Compliance: When Is an Invention a “Subject Invention”?
Due to recent high-profile events at the national level involving universities, the Bayh-Dole Act is again at the top of everyone’s minds. One aspect of compliance is determining what qualifies as a “subject invention” and thus would trigger the compliance requirements.
If technology doesn’t qualify as a “subject invention,” then Bayh-Dole Act requirements do not apply. University Technology Transfer Offices must determine accurately which patent applications are subject to these requirements, and which can be excluded.
The Bayh-Dole Act defines a “subject invention” as “any invention . . . that is conceived or first actually reduced to practice in the performance of work under a funding agreement.” (35 U.S.C. 201(e)).
Notably, if an invention was conceived before a funding agreement was secured, but the subsequent funding has made reduction to practice possible, then it could be deemed a “subject invention” under the Bayh-Dole Act.
However, the line between conception and reduction to practice is a fuzzy one. U.S. patent laws generally consider the filing of a patent application to be a constructive reduction to practice. However, in the case of U.S. provisional applications (which have less stringent disclosure requirements), it may not be clear when reduction to practice actually occurs.
EXAMPLE 1: Professor X conceives of a machine, in the absence of federal funding. The Technology Transfer Office files a provisional application directed to the machine. A few months later, Professor X is awarded a federal grant, and through the funding, can conduct subsequent testing proving that the machine works within a certain range of physical parameters.
EXAMPLE 2: Professor Y conceives of technology directed to methods that encompass one or more genes, in the absence of federal funding. The Technology Transfer Office files a provisional application detailing the methods and listing 500 candidate genes. A few months later, Professor Y is awarded a federal grant, and through the funding, can perform testing on the candidate genes and identify the ones that yield the best results.
In these Examples, when the reduction to practice actually occurred, it can inform whether (and when) the Bayh-Dole requirements are triggered. It is a good idea to revisit this analysis later – for example, if the technology is further expanded.
Technology Transfer Practice Tips:
- Take the time to determine whether all invention records received in your Tech Transfer Office are in fact “subject inventions” subject to Bayh-Dole. This is a legal determination which should be made in conjunction with patent counsel.
- Plan to repeat this analysis at predetermined intervals during the lifetime of the technology – for example, at allowance (before paying issue fees), and in the event that related applications are contemplated (for example, continuation, divisional, or continuation-in-part applications).
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