Intellectual Property (IP) and entrepreneurial activities
Summary and quick links
What is intellectual property?
Why should you protect your intellectual property?
The UVA Patent Foundation
UVA Patent Policy
SOM Clinical and Translational Research Project Directors
Confidentiality and patent rights
Inventions resulting from federal funding
Avoiding problems with IP
Material Transfer Agreements
Confidential Disclosure Agreements
Entrepreneurial activities
What is intellectual property? "Intellectual property" (IP) literally refers to products of the intellect with commercial value. At the School of Medicine, IP might include:
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novel, useful, non-obvious inventions (regardless of whether they can be patented)
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software, written documents, or images that can be copyrighted
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genetically-manipulated organisms
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special antibodies
U.S. patent law defines “invention” as a new and useful process, machine, manufacture or composition of matter, or any new or useful improvement thereof. In order to be patentable, an invention must be novel, have utility, and be non-obvious to others skilled in the art (i.e., colleagues who work in the same area).
Why protect your intellectual property?
- Obligation. UVA policies on patents and copyrights require that employees disclose and assign the title to inventions developed within the scope of their employment or using significant University resources. Under the 1984 Bayh-Dole Act, UVA has the obligation to patent and license inventions developed under federal funding. Recipients of federal funds must disclose to the government any new inventions (see "Inventions resulting from federal funding").
- Royalties and license fees. See the UVA royalty sharing schedule.
- Sponsored research agreements. Licensees of IP often provide research funding to the inventor(s) for additional R&D work required to help bring the invention to market. Such agreements are negotiated by the Office of Grants and Contracts.
The UVA Patent Foundation (UVAPF). Invention disclosures to the University should be submitted directly to the UVAPF, a not-for-profit corporation that whose charge is to protecting and licensing UVA IP. The Foundation notifies the Vice President for Research and Graduate Studies of disclosures it receives. The Foundation:
- evaluates inventions for patentability and potential market value;
- solicits interest on the IP from potential licensees;
- negotiates and manages licensing agreements on behalf of the University;
- in collaboration with its for-profit subsidiary, Spinner Technologies, Inc., helps faculty create start-up companies around their own IP.
Most of these activities require input from the inventor(s). For example, faculty may be instrumental in identifying potential licensees, or might suggest a scientific or licensing contact at one or more companies. Similarly, inventor input is required to generate and file a patent application and to respond to the examiner's questions.
UVAPF uses a "deal-based" business model, under which it directs its time and resources to identify a licensee that would pay for patenting costs and further development of the IP. Inventions that are not licensed quickly are returned or licensed back to the inventors or abandoned. A complete description of the patenting and licensing process can be found in the Patent Foundation’s Operating Manual. Income resulting from licensed technologies flows to the University, School of Medicine, Patent Foundation, and inventor(s) per the UVA royalty sharing schedule. For additional information on IP and the patenting/licensing process, contact a UVAPF Licensing Associate (924-2175).
SOM Clinical and Translational Research Project Directors. Mr. David Chen and Dr. Greg Fralish can help move faculty move their technologies along the development pipeline. These individuals work as facilitators and managers of the development project: bringing inventors together with the UVAPF and Spinner Technologies; identifying critical collaborators; locating investors (if applicable); assessing the market; developing business plans; etc.
Confidentiality and patent rights. Report inventions to UVA Patent Foundation as soon as possible, in order to protect U.S. and foreign patent rights. U.S. law provides a one-year grace period between public disclosure and the filing of a patent application. By contrast, most foreign patent rights are lost immediately upon public disclosure prior to filing a patent application – unless the U.S. filing has taken place before disclosure. Although inventorship under U.S. patent law recognizes “first documented date of invention” in establishing priority, it is likely that this will change to “first documented date of invention.” Such a change would require greater efforts by inventors to maintain confidentiality prior to submitting a patent application, lest an inadvertent disclosure were to result in others filing with the Patent Office.
Inventions resulting from federal funding. Such inventions must be reported to the government, which is granted a non-exclusive, non-transferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world. Most federal agencies (including NSF, NIH, and DOD) use the iEdison system to report inventions (see "reporting requirements for federally-funded IP"). Contact the UVA Patent Foundation for further information on how and when to report inventions to the federal government.
Avoiding problems with IP. Document the conceptualization and reduction to practice of all technology, to establish a priority date. Refer to our section on record keeping. Contact the Patent Foundation as soon as you think you have an invention with potential commercial value. Do not submit a manuscript or abstract describing the technology before conferring with the Foundation, since public disclosure prior to submitting a patent application may restrict patent rights. Any of the following may constitute disclosures:
- paper, recording, microfilm, other fixed communication to others
- meeting abstracts, as of the date they are delivered to attendees
- outside visitors who are not covered by a Confidential Disclosure Agreement.
Material Transfer Agreements (MTAs). MTAs are legal documents allowing the sharing of research materials among scientists for non-commercial purposes. These agreements, which are signed by the provider and recipient institutions:
- identify the materials to be transferred
- define the scope of use by the recipient
- protect the provider’s rights in the materials
- protect the provider from legal claims arising from the recipient's use of the materials
- define IP rights resulting from research using the materials
- describe any reporting requirements (e.g., results of recipient's project)
- ensure that materials derived from human subjects are used in compliance with the consent form
- describe delays that the provider can place on recipient’s publications, in order for the provider to file for patent protection
When you receive materials under MTA, ensure that your research team understands the requirements of the agreement. Your staff should also understand the importance of creating an MTA before sending UVA research materials.
The provider institution generates the initial draft of an MTA (cf. standard UVA MTA for outgoing materials). The Office of Grants and Contracts negotiates and signs all MTAs on behalf of the UVA scientist. Individual investigators should not sign such documents, since this may place them at risk legally.
Possible hold-ups and how to avoid them. MTAs can take a week to several months to finalize. The most common problem encountered during negotiation of MTAs is the ownership of any resulting intellectual property. Many academic institutions accept the streamlined Uniform Biological Material Transfer Agreement (UBMTA; list of participating institutions), which can accelerate the process substantially. If your recipient or sender is at a participating institution, suggest the use of the UBMTA.
Confidential Disclosure Agreements (CDAs). CDAs, also called non-disclosure agreements, are used in several contexts:
- to protect IP rights when discussing your technology with a potential licensee
- required of grant reviewers by funding agencies
- required by sponsors of clinical trials before releasing protocols to potential Principal Investigators
- included as provisions in many consulting agreements
CDAs may be uni- or bi-directional. Like MTAs, CDAs are negotiated and signed by the Office of Grants and Contracts (see standard CDA to protect UVA information).
Entrepreneurial activities. UVA supports faculty who wish to start their own companies in order to bring their own intellectual property to market. The UVA Patent Foundation and Vice President for Research and Graduate Studies have developed "The UVA Faculty Entrepreneur's Guidebook," explaining the process of starting a new company, opportunities for faculty and their companies to license their own IP, types of institutional and other support available to new companies, and management of conflicts of interest due to ownership in a start-up company. Questions on its contents should be directed to the Patent Foundation or the VPR&GS. Entrepreneurs considering starting a company may also consult "The Entrepreneur's Guide to a Biotech Startup," available at this site.