Supreme Court ruling on gene patenting, and modern risks raised by industry/academic interaction, signal need for change
The law that has helped medical discoveries make the leap from university labs to the marketplace for more than 30 years needs revising, in part to ensure the American people benefit from science their tax dollars have paid for, says a University of Michigan Medical School physician and medical historian.
In a new commentary in the New England Journal of Medicine, Howard Markel, M.D., Ph.D., director of the U-M Center for the History of Medicine, looks at the fluke-ridden history of how the law known as Bayh-Dole Technology Transfer Act was passed in 1980. The law made it much easier for research findings made by academics to be patented, licensed by companies and commercialized.
The haphazard history of Bayh-Dole, and the issues and risks that have arisen since it was passed, suggest it is time to re-examine and revise the law, says Markel.
The need for more modern guidance of the process known as technology transfer, and the conduct of ethical and socially just partnerships between academia and industry, was reflected in the recent unanimous Supreme Court ruling that barred the patenting of human genes – though allowed other patents of gene-related discoveries, Markel says.
He traces the history of the Bayh-Dole law, which allows universities and other institutions that receive federal research dollars to grant exclusive licenses to companies that wish to commercialize discoveries made by academic researchers.
Initially conceived as a way to help the United States economy at a time when industry was struggling to keep up with German and Japanese innovation, the proposal only became law because of last-minute wrangling during the final days of a lame-duck Congressional and presidential term.