The Bayh-Dole Act: Mining "The
Endless Frontier"
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The transfer of research from universities to
the marketplace is not new. In fact, ideas originating
in academia have crossed over into commerce for
more than 100 years. In the 1940s, however, presidential
adviser Vannevar Bush authored a widely read report
titled Science: The Endless Frontier, which
highlighted the need for government to support
basic science research that could cross over to
benefit industry, and, in turn, both the economy
and the greater well-being of society. The foundation
of the National
Institutes of Health (NIH) and the National
Science Foundation (NSF) were direct results
of efforts by Bush and others to reinforce university
research in the sciences and ensure practical
applications of that research.
Although the U.S. government began to invest
heavily in university-based research in the 1950s
and 1960s, one stumbling block stood in the way
of the flow of beneficial technologies that Bush
had envisioned. The federal government owned patents
stemming from government-supported work in universities,
but no mechanisms were in place to encourage the
transfer of these patents to industry. Moreover,
as many as 100 separate federal agencies held
these patents, each with different rules and regulations
about transfer and license of rights.
By 1980, the U.S. government held more than 28,000
patents, most resulting from research work funded
in universities and university-affiliated government
laboratories. Less than 5% of these were licensed
to private companies for development. To some
extent this was the result of the byzantine process
of granting licenses, but more important was the
fact that the government held onto ownership of
patents. Companies wishing to develop new products
could never be entirely sure whether the patents
would be renewed or even licensed to competing
companies at the same time. Scientists working
in universities found themselves researching topics
with clear and beneficial applications but with
no promise of significant remuneration for themselves
or their institutions or even control over the
ultimate disposition of patents resulting from
their work.
To remedy this situation, a legislative decision
was made to give up tight government control of
ownership of patents resulting from federally
funded research and actively encourage the commercialization
of such efforts. The Bayh-Dole Act was passed
in 1980, with substantial amendments dealing with
implementation in 1984. Under the provisions of
the act, universities could license inventions
and research discoveries directly to business
and work directly with companies on ongoing and
mutually beneficial research projects. Almost
overnight, university labs that had previously
funded research exclusively through series of
government grants, only to see the products of
such research languish without further development,
found themselves the focus of business interest
and significant new sources of income.
Among the provisions of the Bayh-Dole Act as
it is currently enforced are:
- Universities must have clear and explicit
written agreements with faculty and staff about
disclosure and ownership of inventions.
- Universities must notify the federal funding
agency sponsoring research about every new invention
within 2 months after the inventor notifies
the university in writing. This is required
for ALL inventions funded either partially or
entirely by the government.
- Each university now may decide whether to
keep ownership of the invention and has a 2-year
window in which to decide.
- Universities must share the revenue from licensing
inventions with the inventor(s) of record.
- Profits made by universities from licensing
inventions must go exclusively to support scientific
research or education.
- The university must file a patent application
within 1 year of making this decision, and must
also decide whether to file foreign applications.
- Universities must give preference to small
businesses (ideally in the United States) in
marketing and developing inventions. The result
has been a tremendous upswing in the number
of tech-to-market small businesses that spin-off
university-based inventions.
- The U.S. government retains a "right
to practice" or limited right to develop
the invention "on behalf of the U.S.,"
a clause that is seldom invoked.
- It is the responsibility of the university
to report to the government on ongoing efforts
to commercialize and develop the invention.
- The government retains "march-in"
rights to take title to an invention and grant
licenses. This provision was made for circumstances
in which a university fails to license or develop
a potentially beneficial discovery or where
a new discovery has significant public health
or safety implications.
For more information, see the comprehensive assessment
of the effects of the Bayh-Dole Act by David C.
Mowery et al.
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