A detailed article on the Biden administration’s Executive Order on domestic manufacturing requirements for federally funded inventions and its potential impact on TTOs appears in the September issue of Technology Transfer Tactics. To subscribe and access the complete article, or for further subscription details, click here.

The Biden administration’s long-rumored Executive Order on “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs” landed in late July, and while laudable in its intent, there is little indication of how it will actually affect technology transfer offices, observers say. Most are just relieved it didn’t follow in the footsteps of what has been described as the “deeply flawed” DOE policy.

The Executive Order promises streamlined processes for reporting and getting waivers, which will probably require more administrative action but should eventually usher in a more efficient process with less uncertainty. It’s up to the federal agencies to develop these processes, and there are multiple deadlines the agencies need to meet in the next year.

Among the provisions is that agency heads must consult with outside stakeholders, including industrial partners, academic institutions and others involved, and transition to the iEdison system by the end of federal calendar year 2025. Agencies must also identify critically important technologies vital to the United States’ economic development and national security. (See the full executive order here.)

Joseph Allen, executive director of the Bayh-Dole Coalition and president of Joseph Allen & Associates, is cautiously optimistic. “There’s nothing on the face of it that I object to. I think it’s pretty pragmatic. But when you’re dealing with all these agencies, and you put something new like this on the table, implementation is going to be key because there is a lot of instruction in it. The central thing is that there is going to have to be an adult in the room. Someone who can hold people accountable.”

Allen’s optimism exists because this Executive Order is far different from the regulations issued by the Department of Energy in 2021. The DOE policy offered little wiggle room for licensees and even prompted some TTOs to stop shopping their DOE-funded inventions to industry given the onerous domestic manufacturing requirements. “We were expecting the DOE policy was going to apply to everybody, and that would have been a disaster,” says Allen. “The DOE policy is actually discouraging commercialization as opposed to encouraging it. If you take this Executive Order as written, there is enough leeway in there, and it’s pragmatic enough that it actually could help clarify the system.”

The waiver system, he says, is in particular need of reform. “Under Bayh-Dole, a lot of agencies never respond to a waiver request, so if a federal lab or a university has a company which is looking for an exclusive license, and they’ve done all the work and they can’t find a domestic manufacturer, you put in a request and never get a response back. That’s unacceptable. One thing I really like about this Executive Order is that it instructs the agencies to acknowledge that it’s gotten the request within 10 days and answer it as soon as possible.”

That said, “…the Executive Order wants to make sure that people are reporting under iEdison. Nothing wrong with that on the surface, but again it also says without making it burdensome for the university,” Allen says. “That’s key. A lot of the time the bureaucracy gets carried away with the reporting requirements and they are not cognizant of what that imposes on the tech transfer office. There have been a lot of complaints about iEdison and reporting, so how do we do this in such a way that we’re letting the agencies know this is the license, it’s been commercialized and is being manufactured here, and not make that a morass requiring all kinds of staff time just answering federal questions over and over again.”

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