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Intellectual Property
It is expected that originating parties will have acquired intellectual
property protection prior to involvement of NCI. Normally, NCI will not acquire
intellectual property rights to inventions made by its employees with Research
Materials under DCIDE unless the originating investigator and NCI mutually
agree that to do so would be in the best interest of the project. If the NCI
does file a patent application, the originating investigator will be given the
opportunity to negotiate for an exclusive license under procedures set forth in
37 CFR Part 404.
Many DCIDE tasks will be accomplished by the use of NCI's development
contracts. Normally, an NCI contractor may elect to retain rights under the
Bayh-Dole Act for any contributions it makes that rise to the level of
invention. NCI contractors have, as a term of their funding, agreed to offer a
first option to the originating investigator for license negotiations. Certain
other contractors or subcontractors may be subject to a Determination of
Exceptional Circumstances through which their rights in subject inventions made
using Research Materials may be assigned to the originating investigator.
Should an invention occur, the originating academic party will thereby have
acquired a valuable potential ally in commercializing the subject of the
research and may have acquired additional intellectual property if the
invention was derived from collaborative research. DCIDE Material Transfer
Agreements will form the basis for sharing Research Material and confidential
information with NCI.
Industrial Intervention
If a company decides to license a compound while it is in active development in
the DCIDE program, NCI expects the company to assume a fair share of the costs
required to complete the pre-clinical development and to meet all regulatory
requirements for clinical trials.
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