On
Technology Transfer
A
year ago, NCI postdoc Doug
Loftus interviewed former NICHD branch chief Michael Zasloff, who
had delivered a talk here on the therapeutic implications of his NIH
research a decade earlier and his leaving NIH and founding a company
to bring the research to marketable clinical fruition. Loftus’
article "Swimming
with the Sharks: A Maverick Former NIH Scientist’s Life in
the Corporate Waters" was printed in the July-August 1998 issue
of The
NIH Catalyst, along with a sidebar on "Tech
Transfer Today" at NIH, briefly reviewing the operations of
the NIH Office of Technology Transfer, which did not exist at the time
Zasloff took his research into the world. OTT senior licensing specialist
Steve Ferguson,
who in June participated in a daylong seminar here on "Interacting
with the Biotechnology and Pharmaceutical Community: What Scientists
Need To Know," revisited the Catalyst article and picked
up on something he thought might be misleading. The following exchange
resulted.
The "Tech
Transfer Today" article in the July-August [1998] issue may give
the impression that the only time an inventor can obtain commercial
rights to an invention is if OTT is unable to find anyone to license
it and waives title to the invention. This is incorrect. There are quite
a few examples of NIH inventors leaving NIH to join or help start companies
who then come back to NIH for licenses to the technology originally
discovered at NIH. Once they have left NIH, the inventors (and their
companies) have just as good an opportunity (and probably better, at
times, given their scientific expertise in the technology) to obtain
such licenses.
Two examples that
quickly come to mind are Barrie Carter (formerly of NIDDK), now Director
of Research & Development at Targeted Genetics Corporation in Seattle,
Washington, and Randy Kincaid (formerly of NIAAA), now President of
Veritas, Inc., of Potomac, Maryland. Targeted Genetics subsequently
licensed several of Carter’s gene therapy technologies from NIH,
one of which Carter has been able to take into Phase II clinical trials.
Veritas licensed some of Kincaid’s calmodulin reagents from NIH
for research product sales and distribution.
Thus, the Zasloff
example is not that unusual—many scientists go from NIH to corporate
scientific and/or management careers.
—Steve
Ferguson
Senior
Licensing Specialist, OTT
I was under the
impression that the mechanisms in place at the time of Zasloff’s
discovery enabled him to have been granted the license while he was
still an NIH investigator, albeit with the intention of subsequently
recruiting capital and founding a company. Kincaid and Carter, on the
other hand, were not NIH investigators at the time of licensing, but
rather were already representing commercial entities and not at an advantage
for licensing simply because they were the inventors.
I recall being
told that licenses are not granted to an inventor at NIH unless no outside
commercial entity expresses an interest, which is consistent with the
procedures followed by Kincaid and Carter.
—Doug
Loftus, NCI
I think there
may be some confusion between waivers of inventions and licensing of
inventions. The difference is that a waiver gives up ownership (title)
of the property to the inventor, while a license is either an exclusive
or nonexclusive lease in which the NIH does not give up ownership or
title.
NIH inventions
can be waived to inventors—generally, this involves inventions
that don’t seem to be patentable and/or licensable and in which
the government determines it is no longer interested. When an invention
is determined to be licensable (either as a patent license or biological
material license), ownership is generally kept by NIH and licenses are
granted by OTT. The royalties collected from these licenses are shared
between the inventors (whether they are still here or not) and their
institute.
A conflict of
interest can arise if the inventor who receives ownership or a license
to the invention is still at NIH, as these become personal interests
of the inventor and could conflict with the inventor’s official
duties. For example, an inventor can’t use employment time or resources
for any projects related to the invention. Such ethical issues and consequences
are important for inventors at NIH—hence a whole session on this
subject at the recent tech transfer conference for NIH scientists, as
well as specific written guidance interpreting the conflict-of-interest
laws as they apply to technology transfer (see <http://www.nih.gov/od/ott>).
It is highly unlikely under current guidelines that an inventor could
commercialize an NIH invention (waived or licensed to them) while still
an employee here.
Often, the situation
is highly competitive when an inventor’s company approaches OTT
for a license. In the Carter case, for example, his basic gene therapy
background technology was granted to four different firms nonexclusively.
Another Carter technology, a specific cystic fibrosis gene therapy vector
appropriate for exclusive licensing, was awarded to his firm—which,
again, was one of several applicants. The Zasloff technology dates back
to 1987, with the license agreement signed in 1989, the time he left
NIH. This case predates OTT, so the coexclusive license was granted
by the Department of Commerce through the usual competitive licensing
procedures.
Your Zasloff article
captures the basic motivation of why some inventors leave NIH: the chance
to directly control and further participate in corporate efforts to
make their ideas "real." As you can appreciate, to have such
an ardent champion for the technology at a company is quite important
in having the resultant product reach the public.
—Steve
Ferguson
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