GOVERNMENT AS PARTNER
The government can be an active partner in developing or adding value to early-stage technologies, or finding new uses for
existing technologies. In particular, NIH intramural scientists collaborate with companies in conducting both basic and applied
research through collaboration agreements, Clinical Trials Agreements, Material Transfer Agreements, and Cooperative Research,
and Development Agreements (CRADAs). These agreements are negotiated and executed at the individual NIH Institutes and Centers.
Thus, inquiries regarding opportunities for specific research collaborations should be directed to the relevant Institute
and Center, particularly the Technology Development Coordinator.14 None of these agreements permits the NIH to engage in industry sponsored research that is not collaborative. CRADAs must
involve a proprietary or intellectual contribution from both parties. It is important to note that the new ethics guidelines
at NIH eliminated outside consulting, but did not change an intramural scientist's ability to engage in collaborations with
companies as part of official NIH duties.15
CRADAs are required in order for the Government (1) to grant the collaborator the right to license inventions that may be
made by the government researcher within the collaboration, or (2) to receive money from a collaborator to cover some of the
costs of research, but a financial contribution to the NIH laboratory is not a general requirement.16 The license option grant is important because the government otherwise must advertise and receive public comment on its
intent to grant an exclusive license to a party.17 When the intent to grant an exclusive license to an invention is open for public comment, there is a risk that a highly
qualified party may request a license as well.
Several products have been brought to market through licensing and collaborative research and development under CRADAs. Havrix,
GlaxoSmithKline's hepatitis A vaccine, includes background technology licensed nonexclusively by GSK and improvement technology
invented and licensed exclusively to GSK under a CRADA with the National Institute of Allergy and Infectious Diseases. Taxus
Express, a paclitaxel-eluting cardiovascular stent, was licensed by Angiotech, a Canadian company, and developed under a CRADA
with the inventor's laboratory in the National Institute of Aging. It was then brought to market under a sublicense to Boston
The CRADA has been a successful mechanism, but is not the only method companies can use to collaborate with NIH scientists.
Since 1990, the NIH has entered into more than 1,600 CRADAs with about 350 companies. There are currently about 230 active CRADAs at NIH. Beginning in 1996, NIH
developed a special model CRADA agreement, a Materials-CRADA or "M-CRADA," when the collaboration involves only the transfer
of proprietary materials from a company and in return, the company wants the right to elect an exclusive license to any new
inventions. CRADAs run the full gamut of research—they may involve basic or clinical research, test a scientific hypothesis,
or involve the development of an existing technology.
Among all types of CRADAs, only about 10% have resulted in inventions made by NIH scientists. Half of these inventions have
arisen in CRADAs with small US companies, even though they represent 38% of the total; about one-third of the inventions were
made under CRADAs with large US companies. The remaining inventions fall equally between CRADAs with foreign large and small
companies. It appears that this mechanism is important in preserving the option for a collaborator to elect an exclusive license
should one arise, rather than having been driven by the expectation of an important invention being made.
It is useful to remember a few points related to the CRADA mechanism, in the context of licensing regulations. The NIH model
agreements for CRADAs and M-CRADAs can be found on the OTT web site19 and represent a staring point for negotiating the CRADA with an Institute or Center for a particular collaboration. NIH
will agree to keep company proprietary information confidential to the extent permitted by law.20 With respect to information generated by its scientists, NIH can agree to file patent applications as appropriate and allow
the collaborator to review and comment on documents prior to public disclosure; but NIH does not allow the collaborator to
have veto power over the publication.