I spent more than a decade leading the National Institutes of Health’s (NIH’s) technology transfer office, which negotiated agreements with private-sector firms to turn NIH scientists’ lab breakthroughs into real-world, lifesaving products. During those years, I saw the public and private sectors come together to make America the unquestioned world leader in medicine.
And that leadership didn’t happen by chance. It was the deliberate result of the little-known Bayh-Dole Act of 1980. But now, that law 鈥� and the trillions of dollars in economic activity and lifesaving scientific progress that it catalyzes 鈥� is under threat.
Prior to 1980, taxpayers were funding scientific research that was leading to groundbreaking discoveries. But the government had neither the means nor the desire to turn initial discoveries into concrete products.
Bayh-Dole broke the logjam. It empowered universities, nonprofits and small businesses funded by NIH and other federal grants to retain the patent rights on their own inventions. That shift unleashed a wave of innovation. Since 1996, more than 200 new drugs and vaccines that originated from university and federal laboratory research have come to market. These efforts helped create more than 6.5 million jobs and generated more than $1 trillion in economic output.
Yet today, the Bayh-Dole framework is under attack. Critics argue the government should use a narrow clause in the law 鈥� so-called “march-in rights” 鈥� to relicense patents on brand-name drugs to generic manufacturers, which could produce cheaper knock-off versions.
That’s not what the clause was designed for. March-in rights exist as a backstop for four specific scenarios outlined in the legislation 鈥� none of which is related to the price of a resulting product.
The law is clear: march-in rights can’t be used to regulate prices. I know this firsthand. When I was at NIH, I was repeatedly pressured from outside NIH, by lawmakers, officials and journalists, to use march-in as a price-control tool. One of the most public cases involved Xtandi, a prostate cancer drug developed with federal support. Some demanded the government relicense it to lower its cost. But after reviews under both Democratic and Republican administrations, NIH correctly concluded the law didn’t allow it. The company had met its obligation to bring the drug to patients. Invoking march-in in that case would have violated the law and damaged the trust that fuels biomedical investment.
If private firms believe the government will take the fruits of their labor, they won’t license those patents in the first place.
That would undermine the United States’ dominance in the sector. Before Bayh-Dole, Europe introduced more than twice as many new drugs to the world as the United States. Now, nearly two-thirds of new drugs originate in America. We must not lose our leadership.
As we mark the 45th anniversary of Bayh-Dole, we must remember its origins: a bipartisan solution that allowed science and taxpayer-funded research to deliver public benefits. Our job now is to ensure this system continues to succeed. That means resisting the temptation to reinterpret the Bayh-Dole Act even in an effort to improve the affordability of and access to prescription drugs for consumers 鈥� there are better, less self-defeating ways to achieve that important goal. It means honoring the original intent of the law: to move discoveries from lab benches to hospital beds, for the benefit of all Americans.听
Mark L. Rohrbaugh Ph.D., JD is the former Director of the National Institutes of Health Office of Technology Transfer.听
