Intellectual Property

Does Bayh-Dole Need an Update?

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After nearly 35 years in practice, is it time to look at the Bayh-Dole Act through new eyes?

That’s the case Howard Markel M.D., Ph.D., recently made in the New England Journal of Medicine. In "Patents, Profits, and the American People — The Bayh-Dole Act of 1980," published Aug. 29, Markel, a well-known scholar in the history of medicine (view his complete, and very impressive, bio here) who has served as a consultant for the Department of Defense and the Centers for Disease Control and Prevention, discusses how the Act was passed and signed into law, and suggests that developments that have occurred since 1980 require that Bayh-Dole be reevaluated. He writes:

[Bayh-Dole’s original] aim was primarily to stimulate economic growth by more efficiently mining the untapped scientific riches of hospitals, laboratories, and universities. Much has changed since then.

Moreover, some of the most vexing quandaries weren’t fully addressed in the original legislation. In Myriad, the Supreme Court has taken on one such question: Who should benefit from discoveries pertaining to nature or the human body? But others remain—for example, what conflicts of interest must be identified and contained in order to protect patients? How can scientific discovery proceed if all innovations and research tools are patented and the discoverers control access to them?

It’s time for Congress to recalibrate Bayh-Dole. Profits and patents can be powerful incentives for scientists, businesspeople, and universities, but new and ongoing risks—including high prices that limit access to lifesaving technologies, reduced sharing of scientific data, marked shifts of focus from basic to applied research, and conflicts of interests for doctors and academic medical centers—should be mitigated or averted through revisions of the law. All Americans should be able to share in the bounties of federally funded biomedical research.

So, does Bayh-Dole need to be updated as Markel suggests? As technology transfer professionals, our readers are on the front line of questions like these, so tell us what you think! Let us know in the comments, or on Facebook and Twitter.