Bayh-Dole Draft Concerns - Member Bonus episode
22m | Jan 29, 2024As the clock ticks towards the closure of the 60-day comment period on Feb. 6, and NIST prepares to review and finalize guidance, there are still some crucial concerns regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, a tool created to evaluate when it might be appropriate to require licensing of a patent developed with federal funding.
The Bayh-Dole Act, a key driver of public-private partnerships and innovation in the U.S., is at the heart of today's discussion. We'll explore AUTM's position, the act's original intentions, and the potential impacts of the Draft Guidelines on innovation and intellectual property.
Joining the conversation is Mike Waring, AUTM’s Advocacy & Alliances Coordinator and President/CEO of Waring Federal Strategies. With nearly 20 years at AUTM, including roles as Assistant VP of Advocacy and Cabinet Chair, Mike brings a wealth of experience in tech transfer and IP issues.
Mike's background includes serving as Director of the University of Michigan’s D.C. Office, chairing the AAU Task Force on Intellectual Property, IT, and Tech Transfer, and working in various capacities with AUTM on advocacy issues. His previous roles also include working at the National Association of Broadcasters and as a legislative aide for Rep. Harold Rogers.
In This Episode:
[02:39] The Bayh-Dole Act is one of the most transformational pieces of legislation that Congress has worked on. Now that it's been around for 40 years people are taking it for granted.
[03:55] It incentivizes universities and nonprofits to take great ideas to market.
[04:52] AUTM believes that using march-in rights to lower drug prices is improper under the Bayh-Dole Act. There were limited uses for march-in to make sure that technologies actually get to the marketplace.
[06:23] Congress didn't leave wiggle room for march-in rights to be reinterpreted. They were very clear about the limited uses of march-in. Having it interpreted by countless agencies will be a recipe for disaster.
[07:38] Pricing terms didn't work 30 years ago. Lesson learned.
[08:40] There's bipartisan support that the Bayh-Dole Act does not allow march-in based on drug pricing. There have been attempts over the years to invoke it, but it's never happened.
[10:13] The last two directors of the patent office have said publicly that this is a horrible idea, and it shouldn't be pursued.
[10:56] This will affect every invention that uses federal money.
[11:38] Adverse consequences include investors not taking the risk and stopping funding for innovation and tech transfer.
[13:37] Pricing is an aftermarket decision. It would be like going back on a promise that was made before to investors.
[14:44] If people aren't willing to invest in new technologies our country could fall behind.
[14:56] Mike talks about the guidelines that AUTM finds concerning. Companies could take patents away from the inventors if they are willing to sell for less.
[15:38] What would be the process of people in the government making very individualized decisions?
[16:20] Big companies will be favored over small companies and startups won't have the resources to defend themselves. It's ill-conceived to have the government making decisions without specialized guidance.
[17:21] We need as many AUTM members as possible to file comments.
[20:07] For more information be sure to attend the upcoming Webinar hosted by AUTM on Monday, January 29th.
[20:42] There will also be a policy session at the AUTM Annual Meeting in San Diego on Monday, February 19th at 11:00.
Resources:
Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
AUTM Annual Meeting February 18-21, 2024 San Diego
