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.
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.