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Universities are incubators for many of our nations’ most popular products, from the HyRed blueberry developed at the University of Wisconsin-Madison to the Honeycrisp apple created at the University of Minnesota. Universities have also created hybrids of corn, varieties of soy, drugs for humans and livestock, and countless other inventions.
University research in danger
But colleges and universities across the country fear these research centers are in danger. Thirty-six members of Congress are trying to weaken the Bayh-Dole Act, a law in place since 1980 that allows universities to patent and license inventions created through federally funded research.
Kevin Walters is the strategic research coordinator at the Wisconsin Alumni Research Foundation at UW-Madison. WARF is the organization responsible for marketing the HyRed cranberry and hundreds of other UW-Madison inventions, including the drug warfarin, a blood thinner commonly used in humans. It was developed in the 1940s at UW-Madison and named after WARF.
Walters says weakening the Bayh-Dole Act would be disastrous for organizations like WARF at universities across the country, as well as for US consumers.
University technologies would struggle to attract investment in the industry if, after research and development has already been done, a government agency believes the end result is too expensive and interferes with contractual licensing arrangements, it says.
According to AUTM, a national organization of technology transfer professionals, nearly 70% of academic inventions are licensed by small businesses, many of which depend on venture capital.
Emily Bauer, WARF licensing director, explains how partnerships between universities, the federal government and a company work in the case of creating new blueberry varieties.
Technologies are invented on campus, Bauer says. Development is done by companies that can do much larger trials than anything we can do on campus. WARF owns the patents. Companies want to make sure that if they invest in a technology, they will be able to develop it. If they have to face the potential of the government taking them away, they won’t take the risk. If companies are concerned that their agreements with us may be undermined or canceled after the fact, they will not work with us.
The lawyer Bayh-Dole
Joe Allen worked on the staff of Senator Birch Bayhs in 1980 and helped get the Bayh-Dole Act passed.
I was in the right place at the right time, he says. Forty years later, Allen works as a consultant and heads the Bayh-Dole Coalition.
I work to explain to people what the Bayh-Dole Act is about, Allen says. We want it to work as it was written. There are people who are trying to weaken it. We are trying to keep the flame pure.
Allen explains that before 1980, universities could not have many of the discoveries resulting from their research.
The government claimed patent rights for all federally funded research, regardless of whether federal employees were the ones conducting the research or whether federal grants funded only a small percentage of the work, Allen says.
As a result, inventions ripe for commercialization remained on the shelf.
The federal government lacked the know-how and ability to turn the research conducted by scientists into real products. Of the 28,000 patents owned by such agencies, only 5% have been licensed to the private sector, he explains.
Common sense solution
Sens. Birch Bayh, D-Ind., And Bob Dole, R-Kan., Realized that politics needed to change and convinced their colleagues to approve the reform, Allen says. President Jimmy Carter signed the law of the same name one month before leaving office.
The Bayh-Dole solution was simple, Allen says. The law requires universities and nonprofits to make good faith efforts to commercialize federally funded research. In return, research institutes could keep the patents, providing a strong incentive to license them to a private sector company that could realize the full value of their inventions. The Bayh-Dole Act set the stage for 40 years of technological innovation, job creation and improved quality of life.
Allen says there is a lot of interest in the Bayh-Dole model in other countries. Many countries want to adopt this model.
Allen says the US and the world are fortunate that the Bayh-Dole Act was in effect in 2020 when the pandemic struck.
Thanks to Bayh-Dole, we have vaccinations that work, Allen says. Vaccines were made possible thanks to federally funded research. We have developed effective vaccines in months rather than years thanks to unprecedented cooperation between universities, the federal government and industry. Without Bayh-Dole, this would not have happened. A year ago, we were all praying that someone could develop a vaccine. It was done in record time and is literally saving the world.
Those who want to weaken the Bayh-Dole Act argue that drug prices are too high and weakening the Bayh-Dole Act would lower them. They believe that if a product is made from a federally funded invention and if someone complains that the product is too expensive, the government should allow copycat companies to make it.
We don’t want drugs to be expensive, but we’re not in control, Walters says. Pharmaceutical companies control the prices of drugs. If the product is difficult and expensive for the consumer to purchase, it is probably expensive to make.
The decision is imminent
Allen says a regulation is pending to ensure Bayh-Dole will continue to be implemented as written, but opponents are urging the Biden administration to weaken it. The decision will be made shortly. Opponents can’t amend the law in Congress, so they want to change the way it’s implemented, Allen says. They want to take us back more than 40 years.
President Biden supported Bayh-Dole 40 years ago when he was in the Senate. There is a lot of pressure on the Biden administration to abuse Bayh-Dole. We did that experiment, it just doesn’t work. If they weaken the way the laws are enforced, I think the system will collapse. If that happens, it is best to pray that we will never have another pandemic, because our system of public-private sector research alliances will be in ruins. Let’s hope the administration won’t let that happen.
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