Applicants/institutions retain any intellectual property (IP) generated prior to the initiation of a TRND collaboration as background IP. The potential for development of new, multi-party IP will depend on the stage at which the project begins collaboration with TRND. However, all TRND program collaborators should anticipate joint IP development with NCATS employees. Inventorship of any new, multi-party IP created from the TRND collaboration will be determined according to U.S. patent law and governed under the collaborative agreements executed at the outset of the partnership.
To ensure sufficient freedom to operate on the agent proposed in the application, the applicant must provide a clear description of the relevant patent space and status of the IP. This includes a list of any patents issued or pending with respect to either the agent to be developed or to any commercially unavailable technology or material required for the development of the proposed agent. In the event that a project requires the use of commercially unavailable technology or equipment that is patented by a third party, the applicant must provide documentation that the patent holder does not object to the applicant’s use in support of the proposed TRND project.
Each TRND application must include the information described below, signed by an authorized staff member overseeing IP and/or technology transfer at the applicant’s institution or company. This verifies that the request has been reviewed and that the technology is eligible for consideration by the TRND program. If technology central to the proposal is found to be ineligible for use as outlined in the TRND application, submission to the program is not encouraged.
The following information will be required:
- Description of the patent space/freedom to operate around the proposed agent. This is especially important for, though not limited to, lead optimization projects likely to require significant medicinal chemistry support.
- Details of all the following rights that are owned by the applicant institution and that will be used in the project (the “institution’s IP”):
- Patents and patent applications
- Significant know-how
- Registered trademarks, applications for registered trademarks and other marks
- Registered designs, applications for registered designs and significant other designs
- Significant copyright works and other IP rights
- Details of all employees, consultants and other parties involved in the development of the institution’s IP related to the TRND project submission. If there are contributors from outside the institution, describe their role in development.
- A complete list and brief description of all agreements with third parties related to the TRND project submission:
- Granting rights to those third parties under the institution’s IP
- Granting rights under third-party IP to the institution
- A complete list and brief description of all confidentiality agreements with third parties related to the TRND project proposal.
- Details of any:
- Claims made by third parties against the institution related to the project proposal that the institution has infringed a third party’s IP rights
- Circumstances where a third party has or may have infringed the institution’s IP or other IP used in the institution’s business related to the project proposal