T H E   N I H   C A T A L Y S T     J U L Y  –  A U G U S T   1999


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

On an NIH Graduate School

I am responding to the request for input on the NIH graduate program, based on the town meeting [May 24], which I attended. My overall impression of the town meeting was as follows:

1. It is clear that the members of the NIH community highly value the town hall meeting. Michael Gottesman was right to say we should have more.

2. The case for an NIH postgraduate training program was made well and convincingly; the case for an NIH graduate school less so.

There are two phases to the dialog about an NIH graduate school. First, is it necessary: Can the NIH enhance the productivity and progress of the scientific enterprise by having a graduate school? Second, could an NIH graduate school be the right size to make a difference without detracting from the NIH Intramural Research Program mission? On the issue of necessity, we should probably listen very carefully to our extramural peers on this subject. . . . Can we convince ourselves and then them that we can train a group of scientists at the graduate level who truly have a unique and important impact on biomedical research? Do we have the institutional will to do it on a scale that will matter? Will that distract us from more important things? What will the "product" look like?

There was much talk of a training program with a strongly clinical flavor, but not too much about how to train someone for clinical research without offering a clinical degree as well as, or in addition to, a research degree. Should NIH be offering a public health degree? Would impact be highest if a graduate program were restricted at least initially to training only in bioinformatics or only in biophysics?

Lee E. Eiden, NIMH

—For follow-up, see "NIH Morphs Graduate School Idea"–Ed.




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