A Biden administration proposal concerning patent rights from institutions that take funding from tax dollars has raised alarms at one manufacturing group in Michigan, a key electoral swing state.
The proposal in question, put forward by President Joe Biden's administration, concerns the federal government's ability to exercise "march-in rights" under the Bayh-Dole Act.
Passed into law in 1980, the act allows certain entities, like universities and manufacturers, to own, patent, and profit from inventions produced by programs that received federal funding. The act also bestows the federal government with march-in rights, allowing it to compel these entities to license their federally-funded patents to other applicants or lower the prices associated with them.
Since the law's inception, these rights have never fully been utilized, but under the proposed new framework, the federal government would be able to use Bayh-Dole march-in rights, with the Biden administration saying that this step would help bring down prescription drug prices, a key area of focus for the president since taking office.
Writing in a Sunday opinion column for the Traverse City Record-Eagle, Dave Worthams, director of employment policy for the Michigan Manufacturers Association, wrote that the "scary" proposal would take his state back to the 1970s, when the federal government could enact complete control over federally funded inventions, which he said led to only around 5 percent of the patents being licensed, compared to the 69 percent that are estimated to have been licensed since then.
"According to the Bayh-Dole Coalition, the act led to nearly 69 percent of innovations — that's a lot more than 5 percent — being used and developed," Worthams wrote. "It has led to the creation of life-saving medicines, TV and internet technologies, and more. It isn't a stretch to say it's a good government reform that's saved lives and revolutionized the way the world communicates. In other words, the stakes are pretty high. The latest federal guidance could take Michigan back to the '70s. Clean energy, medicine, agriculture, higher education — they'd all be impacted."
The move has, however, caused considerable consternation among universities and manufacturers, who have counter-argued that the new framework would enable the government to act in ways that go against the intent of the Bayh-Dole Act.
In his opinion column, Worthams encouraged readers to submit complaints about the proposal to the Federal Register, which is currently soliciting public input.
Newsweek reached out to the White House via email for comment on Sunday afternoon. Any responses received will be added in a later update.
Speaking with CBS News recently, Dr. Aaron Kesselheim, a professor of medicine at Brigham and Women's Hospital in Boston, said that the use of march-in rights could, in fact, be a beneficial and "reasonable" way to lower prices for specific products.
"For the last 40 years, the NIH [National Institute of Health] has basically refused to consider march-in rights in the case where a drug was being made available at an extremely, excessively high price," he explained. "I don't think it's going to have a major impact across the market, but for those very small number of cases where the public invests a substantial amount of money in the development of a product and then that product is sold at an extremely high price, that this is a reasonable tool that the government can use to try to address that situation."
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Thomas Kika is a Newsweek weekend reporter based in upstate New York. His focus is reporting on crime and national ... Read more
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