Madison, Wis. – As law professors at major universities, Rebecca Eisenberg and Arti Rai want to make their case perfectly clear: they are not calling for repeal of Bayh-Dole, the landmark law that gave universities the right to patent their inventions. They are advocating an adjustment that they believe will advance biomedical discovery.
Eisenberg of the University of Michigan and Rai of Duke University have been placed among the most vocal critics of a law that many credit with sparking the nation’s biotechnology industry, but in recent interviews with WTN Media, neither favored a major overhaul.
Their names were invoked during a recent lecture series at the University of Wisconsin-Madison, when former U.S. Senator Birch Bayh, who co-authored the law with former Senator Robert Dole, lashed out at unnamed critics who have called for change.
Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, mentioned Eisenberg and Rai by name, and both men said the law was under attack.
Rai disputed that characterization.
“It’s a very minor tweaking,” she stated. “We sort of see it as a fine point that nobody but a lawyer would care about very much, but it’s been sufficiently controversial that some people have cared about it.”
Eisenberg and Rai are co-authors of a 2003 article titled “Bayh-Dole Reform and the Progress of Biomedicine.” In the article, they argue that a fundamental problem with Bayh-Dole is that it makes no distinction between patentable discoveries that need further development to be useful, and research discoveries that can be put to use immediately for the benefit of scientific investigation. Examples of the latter include new DNA sequences, protein structures, and disease pathways.
Since universities have the opportunity to file patent applications on basic research discoveries, which formerly were in the domain of open science, Eisenberg and Rai argue that this may actually hinder rather than promote biomedical research.
To distinguish between the two kinds of discovery, they cite the example of the automated DNA sequencing machine developed at Cal Tech. Even though the machine is considered a research tool, it needed further development in order to be useful, so a patent on the invention was appropriate.
“It took a lot of investment to get that developed into a reliable machine from a private firm,” Eisenberg said, “and you needed a university patent on that, even though it was a research tool, to be sure that the technology got developed.”
For the benefit of biomedical research, other inventions can be put into use sooner, and the professors believe that Bayh-Dole should be amended to allow federal funding agencies the discretion to distinguish between the two kinds of discovery.
Rai, in a shot a cross WARF’s bow, said embryonic stem cells are not the sort of discovery that need further development.
“In point of fact, there are lots of labs that are coming up with their own stem cell lines routinely,” Rai said, “and so it’s not the sort of thing that you need a lot of industrial development for before it can be used.”
Given the respect Bayh-Dole enjoys in Washington, its proponents probably don’t have much to worry about. Even Rai acknowledged that Bayh-Dole reform has little support in the federal government. She noted that the President’s Council of Advisors on Science and Technology looked at Bayh-Dole last year, and recommended that it not be changed.
In addition to the Eisenberg-Rai proposal, there have been rumblings about implementing price controls on the products of federally funded research, and others have decried the lack of a mechanism to track the progress of federally supported inventions.
Still, nothing has come of any reform idea. “Our particular piece of the proposal, I think it’s fair to say, has gotten no traction,” Rai conceded. “Nobody in Congress has contacted me to say, ‘Oh, there might be something we can do about this.'”