Recent Bayh-Dole Wins Are Gratifying, but the Fight's Not Over 

Joe Allen
Guest Columnist
 

Bayh-Dole is on a roll. In the last six months, our position defending the Bayh-Dole Act’s importance for our nation’s well-being and wealth has been gaining traction.
Consider this:

• The Biden Administration rejected the latest petition to misuse march in rights for government price controls in one of the strongest denials ever issued.
• Senator Bernie Sanders couldn’t secure enough committee votes to force the National Institutes of Health (NIH) to require a “reasonable pricing” provision for any invention created by its funding.
• Despite concerns that the Administration would require all agencies to adopt the misguided Department of Energy policy that all federally funded inventions must be made in the US or require a waiver, President Biden’s new Executive Order rejected that approach.
• The Bayh-Dole regulations were amended, prohibiting parties with no intention of commercializing a federally owned invention from objecting to pending exclusive licenses. Opponents of Bayh-Dole have routinely challenged pending NIH licenses—but no more.

That’s an incredible record, considering that not so long ago it seemed our backs were against the wall. So, what changed?
 
We made a conscious decision to stop playing defense and to boldly proclaim our message. We showed the incredible economic and humanitarian impact of academic patent licensing, and we explained how the law works in plain English. That helped educate the media, which for too long simply repeated the talking points of the other side.
 
A pivotal sign that the tide was turning came in September 2021, when The Washington Post’s Fact Checker column featured a large photo of Senator Elizabeth Warren and assessed her claim that the government could march in to regulate prices under Bayh-Dole.

It concluded: In the two decades since march-in was identified as a way to control drug prices, advocates of this approach have struck out every time they have sought to advance it. No administration or court has ever accepted this reasoning. For now, it remains just a theory, not a tool that has ever been used in this way by the federal government.

The reporter did his homework. Our arguments withstood scrutiny, and our opponents’ didn’t.
It’s gratifying that our message is resonating at a time when our country’s lead in developing innovative technologies is being seriously threatened by China.

But this is no time to relax. There are still serious fights ahead; pending guidance on how agencies use march in rights looks to be the next battlefield. Now’s the time to redouble our efforts and make the most of the momentum we’ve gained.