Don't Let Bayh-Dole End with a Whisper

Joe Allen
Bayh-Dole Coalition
 




We just faced down the most serious threat to the Bayh-Dole Act in 45 years when the Biden administration backed away from finalizing its march-in framework, which would have undermined the law by allowing agencies to second guess how resulting products are priced.  Given that the framework was announced from the White House as part of its attempt to reduce drug prices in the midst of a hotly contested election, that we were able to mount such widespread opposition to block that effort shows the power of our community when roused.

But there’s another way the law can be undone. That’s by piecemeal agency actions gradually re-establishing their micromanagement. While less dramatic than the march-in framework, this “death by a thousand cuts” has the same result. And those cuts have already begun. 

The fundamental purpose of Bayh-Dole is to establish a uniform, decentralized patent ownership policy across all agencies. In his opening remarks at the Bayh-Dole hearings, Senator Birch Bayh said there were then more than 20 different statutes and regulations in place governing how federally funded inventions were to be owned and managed. Bayh-Dole ended that chaos.  

Despite that mandate, without effective enforcement there’s a tendency for agencies to gradually reinsert their control. We saw that most clearly when the Department of Energy announced its draconian approach to domestic manufacturing of inventions it funds, which goes far beyond what Bayh-Dole allows. Now we’re seeing the Department of Agriculture questioning whether germ plasm technologies should be patented and the National Science Foundation floating instructions for how universities can license inventions made with industry sponsors.

All these actions whittle away at Bayh-Dole’s fundamental premise of creating a uniform policy allowing academic institutions and small companies to own and manage their inventions without Washington micromanagement.

One of my goals this year is resurrecting effective oversight of the law. We knew in passing Bayh-Dole that it’s hard for universities to stand up to the agencies awarding their grants. That’s why the law charges the Secretary of Commerce with overseeing implementation of the law. But that has not happened for quite a while.

So, until that void is filled the burden of defending Bayh-Dole falls on us. We’ve just seen what happens when we stand together and make our case. The funding agencies need to know that while we appreciate their support, we don’t intend to passively give up our hard-won rights.

If we won’t stand up to defend ourselves, no one else will.