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 important consideration for University Technology Transfer Offices is determining what qualifies as a “subject invention” and thus would trigger the compliance requirements.

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 can be challenging to discern. 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 X 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.

Technology Transfer Practice Tips:

1. 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.
2. In these Examples, when the reduction to practice actually occurred 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.

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).