We encourage you to contact OTC during your early research activities to be aware of the options that will best allow for optimal intellectual property protection and leverage the commercial potential of your research. OTC staff are trained to assist you with questions related to marketability, funding sources, commercial partners, patenting and other protection methods, new business start-up considerations, University policies and procedures, and much more. Our team approach provides you with an assigned licensing specialist supported by internal legal assistance, and, if a new business start-up is being considered, new business development assistance as well.
Submitting your idea to our office is the first step in the process for protecting and commercializing your ideas. Please submit your idea using an Invention Disclosure Form or IDF (preferably, at least three months before disclosing your idea to the public). However the formal IDF is not a requirement to contact us- we welcome the opportunity to meet with you early in your research to discuss strategies for future development and commercialization. The IDF is a confidential, internal document that summarizes your idea’s usefulness and lists any federal or other financial support. The IDF will ask for a list of contributors and their percentage contribution to the invention, a description of the invention, any materials from third parties and your plans for any public disclosures. Each contributor will need to electronically sign the IDF for the form to be complete. If you are unsure as to how to proceed, please feel free to contact our office and speak to someone directly. Please note that the IDF is not a legal document. It is not a part of the formal patent application process and does not provide any legal protection for your invention. Rather it is just an official submission to OTC to document your invention with us. If more data is added later as the invention matures, you can discuss with OTC how best to add the new invention in a different IDF, or as an amendment to the original IDF.
This is the period in which you and your OTC representative review the invention disclosure, conduct patent searches (if applicable), and analyze the market and competitive technologies to determine your invention’s commercialization potential. Licensing Specialists at OTC examine each invention disclosure to review the novelty of the invention, protectability and marketability of potential products or services, relationship to related intellectual property, size and growth potential of the relevant market, amount of time and money required for further development, pre-existing rights associated with the intellectual property (IP), and potential competition from other products/technologies. This assessment may also include consideration of whether the intellectual property can be the basis for a new business start-up. If OTC decides not to pursue patent protection and/or chooses not to actively market the invention, the University may transfer ownership to the inventor(s). Reassignment of inventions funded from U.S. government sources requires the government’s prior approval. Among the key factors in deciding to reassign are whether additional University resources or private resources could best improve marketability. You will find further information on this topic in the Patent Policy here.
Based on our initial assessment, we may file a provisional patent application. A provisional patent application is valid for 12 months. It is not examined nor published by the US Patent Office, however, it establishes a priority date from which prior art will be determined. At the end of the 12 month period, the provisional patent application needs to be converted to a utility patent application. The steps leading from conversion of this provisional application to an issued patent can be quite complex and extend over many years. The University will pay the costs incurred during this process with the goal of recovering that investment from a license partner. Often the University accepts the risk of filing a patent application before a licensee has been identified. After University rights have been licensed to a licensee, the licensee generally pays the patenting expenses. At times we must decline further patent prosecution after a reasonable period (often a year or two) of attempting to identify a licensee (or if it is determined that we cannot obtain reasonable claims from the PTO). It is important to note that not all inventions need to protected by patents. For example most software, databases and content is best protected via a copyright. Research tools and materials, such as transgenic mice and cell lines, may be maintained as proprietary and licensed without patent protection.
In parallel with the patent protection, we also encourage inventors to continue to develop and grow their technology to proof-of-concept stage. This will de-risk your early stage technology and increase the likelihood of attracting potential licensees and investors as applicable. We have put together a list of internal and external translational grants and entrepreneurial resources to facilitate this process, found in the link below.
With your active involvement, OTC staff identify candidate companies that have the expertise, resources, and business networks to bring technology to market. This may involve partnering with an existing company or forming a start-up. Your active involvement can dramatically shorten this process. For more information and support for creating a start-up or new venture based on your invention, please refer to our Start-up Wiki page. A license is a permission that the owner or controller of intellectual property grants to another party, usually under a license agreement.
OTC is responsible for managing the expenses and revenues associated with technology agreements. Per University Policy, revenues from license fees, royalties and equity—minus any unreimbursed patenting and file expenses—are shared with inventors. Under University Policy, inventors who receive equity from a licensee are permitted to share in revenues received by the University from the associated agreement. License revenues are typically taxed as Form 1099 income. You should consult a tax advisor for specific advice. Revenues waived by inventors are distributed to the associated school/college and department/unit. To avoid potential tax liability, revenues waived by you to your department/unit must not be under your control. While there may be some variation in the procedure, typically when a license agreement is developed, a Revenue Distribution Plan (RDP) is created to document the formula used to distribute any subsequent revenues. The initial RDP includes a draft formula based on the contributions listed in the Invention Disclosure(s) relating to the license. OTC asks one inventor within the group to serve as coordinator and to report the percentages determined by the inventors collectively. All inventors must sign the RDP, signifying their approval. Should the inventors be unable to agree on a revenue distribution plan, OTC will make the final revenue allocation decision. **Please find information on royalty checks, address and direct deposit changes etc on this page.
Please review OTCs Revenue distribution plan (RDP) for understanding how income from the commercialization of inventions is distributed among inventors, affiliated departments and schools, and other involved parties.
Duke Policies and Procedures
- Duke’s policy on Patents, Inventions and Technology Transfer
- Duke’s Copyright Policy
- Duke SBIR/STTR Implementation Procedure
Purpose: To establish a procedure for Duke University faculty and staff participation in the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs.This Duke University SBIR/STTR Implementation Procedure is to be applied in concert with the University’s other policies and procedures, including but not limited to Financial Conflicts of Interest in Research Policy, Institutional Conflicts of Interest in Research Policy, and other policies related to sponsored research.
Sponsored Research Agreements
A Research Agreement is a contract that governs the relationship between the University and a third-party which may fund your lab to support a project of any nature. OTC does not handle Research Agreements at the University, but we do work with appropriate offices to negotiate language related to intellectual property. Please find below a link to the Office of Research Contracts at Duke that manages such agreements for the Medical School/Health System and Office of Research Support for the University. Project representatives from both these offices work closely with OTC on intellectual property issues in sponsored research agreements. If you have questions about sponsored research, please contact your project representative responsible for your unit.
The Sponsored Research Agreement (SRA) should specify the intellectual property (IP) rights of the sponsor. The University generally retains ownership of the patent rights and other intellectual property resulting from sponsored research. However, the sponsor may have rights to obtain a license to any invention or data resulting from the research. Often, sponsored research contracts allow the sponsor a limited time to negotiate such a license. Even so, the sponsor generally will not have contractual rights to discoveries that are clearly outside of the scope of the research. Therefore, it is important to define the scope of work within a research agreement.
Prior to receiving funds from an awarded SRA, you will be required to sign an attestation agreeing that you will comply with Duke’s Policy on Inventions, Patents, and Technology Transfer and assign inventions that result from the SRA to Duke to be administered according to the Policy. See FAQs below for additional information.
Duke University requires all employees to execute a written invention assignment agreement for inventions that employees make within the scope of their University research. This written invention assignment agreement helps Duke meet its obligations under its many sponsored research agreements, including federal grant awards that are subject to the Bayh-Dole Act. These FAQs provide more detail on this issue.
Why am I being asked to sign this invention assignment?
The Bayh-Dole regulations for federally funded grants now require that institutions have a written agreement in which employees assign the right, title and interest in and to each invention made under the federal contract. The assignment helps ensure that Duke complies with its obligations under all research funding/sponsorship agreements, including non-federal sponsors.
The Faculty Handbook states “Inventions resulting from research . . . conducted by University employees in whole or in part on University time or with significant use of University funds or facilities shall be considered the property of the University” and “Employees shall upon request assign to the University all rights to such inventions . . . .” The timing of Duke’s request for the written assignment agreement has been moved to the attestation as a result of the government’s changes to the Bayh-Dole regulations.
What is the Bayh-Dole Act?
The Bayh-Dole Act is a federal statute that created a uniform federal policy for the management of inventions and corresponding patents resulting from government-funded research. This policy is implemented through a standard clause that is inserted into federal funding agreements with universities. In general, under this clause, when the University receives a federal grant, the University must, among other things, grant rights to practice the invention to the federal government. Because of these requirements, it is important for Duke to secure its rights in inventions in writing and in advance so that Duke can meet its obligations under Bayh-Dole.
Is Duke’s requirement that employees sign written assignment agreements unusual?
Most research institutions follow a similar approach as the result of the Bayh-Dole regulations and a 2011 U.S. Supreme Court case Stanford v Roche, which clarified that a University must have a present assignment of inventions rights in its faculty inventions to allow the University to have clear ownership over subsequent parties claiming that the invention was assigned to them. See Stanford University v. Roche Molecular Systems, Inc., 563 U.S. 776 (2011).
What happens if I don’t sign the assignment?
If you don’t sign the assignment, it would be a violation of Duke’s requirement that all employees execute a written assignment of inventions to Duke upon request (see Faculty Handbook, 2019, Appendix P, page 10, Article IV C.). A failure to sign the assignment may result in Duke not allowing the researcher to conduct the proposed research.
Material Transfer Agreements (MTAs) and Non-Disclosure Agreements (NDA or CDA)
Material Transfer Agreements (MTAs) are contracts that regulate the transfer of research materials between two parties. It is important to document items that are to be shared with others and the conditions of use. If you wish to send materials to an outside collaborator, an outgoing Material Transfer Agreement (MTA) should be completed for this purpose. It also may be necessary to have a Non-Disclosure Agreement (NDA), also known as a Confidentiality Agreement (CDA), completed to protect your research results or intellectual property.
OTC does not handle MTAs at the University. Please find below a link to the Office of Research Contracts that manages such agreements.
Conflict of interest (COI)
A conflict of interest can occur when a University employee, through a relationship with an outside organization, is in a position to:
- influence the University’s business, research or other areas that may lead to direct or indirect financial gain,
- adversely impact or influence one’s research or teaching responsibilities, or
- provide improper advantage to others, to the disadvantage of the University.
Examples of COI include the appropriate and objective use of research, the treatment and roles of students or human subjects, supervision of individuals working at both the University and a licensee company, and conflict of commitment (i.e., your ability to meet your University obligations).
A conflict of commitment may exist if duties, assignments or responsibilities associated with a technology license or outside business arrangement have a negative impact on your ability to meet commitments associated with your University employment or exceed the amount of time available to you for these activities. The best approach is to fully disclose your situation to your supervisor and discuss the implications for your job responsibilities.
Learn more at Duke’s Office of Scientific Integrity (DOSI)
Please find some links below to guide you toward information on the University’s COI policies and regulations.
University Conflict of Interest Policy: Information regarding faculty conflict of interest issues and links to conflict of interest disclosure forms.
If you would like to check on any of your technologies, you can login to Innovate through the link below. https://innovate.olv.duke.edu/log_in/