General Research Disclosure Questions
It depends. If you are faculty, staff, visiting faculty/staff or other employee of the University, the University will hold all Legal Rights to all Intellectual Property generated during employment. If you are a student, the University may also hold Legal Rights to Intellectual Property generated by any student if the Intellectual Property created by students was through the use of Specialized Resources or in connection with employment by the University.
Traditional Works such as books, articles, class notes, etc. are, in general, exempt from university ownership unless the Traditional Work was specifically commissioned by the University.
If a Creator is unsure if a specific piece of Intellectual Property would be covered under the University's Intellectual Property Policy, they may submit a Research Disclosure Form and mark it requesting an expedited review to reach a determination of whether the Intellectual Property would be covered under the Intellectual Property Policy.
Yes, you should disclose any Intellectual Property you develop. This helps to ensure that the University is aware of all Intellectual Property generated through research. Under the Intellectual Property Policy all persons covered by the policy are required to disclose to the University (via OTT) any Intellectual Property, except those concerning Traditional Works. You can disclose your research by completing a Research Disclosure Form. Such disclosure should occur prior to a public disclosure.
There are several benefits of disclosing to the OTT. One such benefit depends on whether any Federal Funding was used in the research. Regulations under the Bayh-Dole Act (1980) require that government funded inventions be reported to the federal agency who made the award. As a service to researchers, our office will report a disclosed invention to the appropriate funding agency. Another benefit of disclosing to our office is to allow us to help determine the best strategy for turning the Intellectual Property in the Research Disclosure into a product that would benefit the public good. One such strategy could be by placing the invention in the public domain for non-commercial, academic purposes. Another strategy could be to license the Intellectual Property to a company for further development. Often, Intellectual Property requires additional development which can be expensive (such as clinical trials of a therapeutic). In order to be an attractive opportunity to a company to make such an investment, the Intellectual Property will need to be protected (i.e. patented or copyrighted) so that the company can market the final product exclusively. Without exclusivity, companies are unwilling to make the necessary investment and promising Intellectual Property may not get the funding needed to move it forward to the public. As part of our efforts in marketing an invention to a company, we also encourage companies to continue development of the IP through Sponsored Research. These efforts often help to bring money into the researcher's lab and the University.
The Office of Technology Transfer provides several ways for you to disclose your Intellectual Property. These include:
- Filling out a Research Disclosure Form OR
- Call (852-2965) or email the Office of Technology Transfer (firstname.lastname@example.org) and schedule a meeting with a Technology Manager who will work with you to fill out the Research Disclosure Form.
Anyone who contributed to the inventive concepts that make the Intellectual Property different (i.e. novel) and nonobvious should be included. This could include faculty, staff or students involved in the research. Generally, if someone did work, as directed by another person, they would probably not be listed as a researcher on the Research Disclosure Form.
Research becomes an invention when you have a conception (a solid idea of how to do something), and it has been reduced to practice, either actual or constructive (either you've already done this or have a prototype; or, you have a well-reasoned best way to do it written and supported by data/research. Under U.S. patent law, an invention is defined as
- new and useful processes, and
- the physical embodiments of intellectual effort, for example; machines, manufacture, composition of matter, apparatus, instrumentation, circuits, computer programs, biological materials, chemicals, or any new and useful improvement thereof.
Whenever you feel you have identified a new research discovery that you feel is interesting, novel and important to advancing the field. Don't worry about whether or not you have an "Invention" or "Intellectual Property", we can help you figure that out. You should also disclose any such discovery prior to any public disclosures (such as submitting an abstract or manuscript.)
Proof of concept (demonstrating that the IP will work) is important, but not always necessary. From a patent perspective, proof of concept can either be actual reduction to practice or constructive. It is important that the idea will work as proposed and any data to support the description of the invention is beneficial to make that determination. From a commercial perspective, most companies will not license inventions when proof of concept has not been demonstrated. Whether proof of concept has been achieved will carry weight in the evaluation process. If proof of concept has not been established, the OTT will work with you on identifying the necessary next steps to do so.
The disclosure review process starts with the submission of a Research Disclosure Form. The Research Disclosure Form is reviewed with the Creators for its commercial potential and ability to protect the Intellectual Property. At the end of the review process, the Office of Technology Transfer will notify whether the University has "Elected to Retain Title" to the Intellectual Property. If the university "Elected to Retain Title", it will pursue marketing the Intellectual Property and protecting it per the Intellectual Property Policy. Our goal is to move new Intellectual Property from the research lab to people who can benefit by attracting commercial partners to license the Intellectual Property or further its development through Sponsored Research while protecting the University of Louisville's investment in research.
There are several reasons we ask this question. One relates to the Federal regulations under the Bayh-Dole Act (1980) which requires that government funded inventions be reported to the federal agency who made the award. As a service to grant awardee's, our office uses a system call iEdison to report inventions to the funding agency. Another reason we ask for this information pertains to the Intellectual Property rights under any funding agreement. Although funding agreements with the Federal government are pretty standard and fall under Bayh-Dole, those with private agencies are not and it is important that we know about the funding source to determine those rights.
The University of Louisville and the United States Department of Veterans Affairs has a Cooperative Technology Administration Agreement in place concerning Inventions made by scientists employed by both parties. Under this Agreement, joint inventions will be managed by the University of Louisville for both parties. Knowing whether someone has a VA appointment allows us to fulfill our requirement under this Agreement.
A material transfer agreement (MTA) is the contractual instrument used to define the terms and conditions for the exchange of materials. An MTA typically sets forth rights to use the materials and may allocate rights that result from their use. They often include terms related to publication of results, limitations on the use of the materials, and the intellectual property rights of the provider and the recipient in the results of the research in which the materials are used.
An MTA may be needed when required by the provider of material. Outgoing transfers of materials from University of Louisville laboratories may require MTAs if the materials are the subject of a research disclosure on file with the Office of Technology Transfer, have been licensed to a third party, or are of human origin, toxic or hazardous, or export controlled.
Send an email to the EPI-Center. Please include as much information as you have, including the name of the material, the intended provider or recipient, the provider or recipient’s contact information, and any draft agreements you may have received.
The Office of the Executive Vice President for Research and Innovation has several authorized signatories for signing MTAs, including particular Office of Technology Transfer team members.
A researcher may be asked to sign an acknowledgement of the MTA’s terms and conditions, but only university individuals who are authorized to sign these agreements on behalf of the university have the authority to bind the university to the MTA.
Some MTAs may be reviewed and signed the day they are requested. Others, especially those with private industry or true collaborators, may require additional time to negotiate. Potential problem terms, such as publication restrictions and intellectual property matters, are discussed in greater detail above.
Possibly. Permission may need to be requested from the provider first, or the provider may prefer to send the materials to the requestor directly. Please contact the Office of Technology Transfer at 502-852-2965 for additional information and to discuss your request.
Yes. In order to transfer human tissues, the consent form used to gather those tissues must allow for the transfer of such tissue. EVPRI team members in the University of Louisville Human Subjects Protection Program Office (HSPPO) support two duly established and independent Institutional Review Boards (IRBs), which review and approve protocols for all research involving human participants. In the event the consent form does not provide for the transfer of tissues collected, HSPPO can assist in exploring alternatives.
In addition to IRB review and approval, the University of Louisville Privacy Office will be consulted regarding any data that may be transferred with the tissues. The tissues may be transferred with no protected health information (PHI) identifying information, or special language may be included in the MTA to allow for PHI to be transferred. A Data Use Agreement may also be negotiated, in order to allow a limited data set to be transferred. Lastly, the authorization obtained prior to collection may provide the ability to transfer. The Privacy Office can assist you in this determination.
For the transfer of materials that are toxic or otherwise classified has hazardous, please contact the University of Louisville Department of Environmental Health and Safety. Authorization from the Biological Safety Office will need to be obtained before an MTA transferring such material can be completed.
For the transfer of materials that may be export controlled, please contact the University of Louisville Office of Export and Secure Research Compliance (OESRC). Authorization from the Director of the OESRC will need to be obtained before an MTA transferring such material can be completed.
A patent for an invention is the grant of a property right to the inventor. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. possessions.
The right conferred by the patent grant is, in the language of the statute and of the grant itself, "the right to exclude others from making, using, offering for sale, or selling" the invention in the United States or "importing" the invention into the United States.
There are three types of patents:
- Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof;
- Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and
- Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.
An inventor is the "idea" person who has the creative concepts that make the invention new and nonobvious (see #3 below). A person is considered an inventor on a patent if he/she contributed conceptually to either of the two foundations of patent rights: conception or reduction to practice. Conception is the mental part of inventing, and reduction to practice describes the demonstration that the invention will work for its intended purpose. Inventors employed by an institution or company are often required to assign (legally transfer) their rights in their inventions to their employer. Under the assignment, the employer acquires all patent rights and is listed in the patent as the assignee (owner) although the employee(s) will be listed as the inventor(s).
A patentable invention must be something new, useful and nonobvious, meaning that the invention should not be obvious to fellow scientists in the same field of study.
Examples of lack of novelty:
If the invention has been described in a printed publication anywhere in the world, or if it was known or used by others in this country before the date that the applicant made his/her invention, a patent cannot be obtained. If the invention has been described in a printed publication anywhere, or has been in public use or on sale in this country more than one year before the date on which an application for patent is filed in this country, a patent cannot be obtained. In this connection it is immaterial when the invention was made, or whether the printed publication or public use was by the inventor himself/herself or by someone else. If the inventor describes the invention in a printed publication or uses the invention publicly, or places it on sale, he/she must apply for a patent before one year has gone by, otherwise any right to a patent will be lost. The inventor must file on the date of public use or disclosure, however, in order to preserve patent rights in many foreign countries.
Examples of obviousness:
Even if the subject matter sought to be patented is not exactly shown by the prior art, and involves one or more differences over the most nearly similar thing already known, a patent may still be refused if the differences would be obvious. The subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention. For example, the substitution of one color for another, or changes in size, are ordinarily not patentable.
If the University elects to retain title to your invention and proceed by filing a patent application to protect the intellectual property within the inventions (see #9 below), one of the University's contract law firms will work closely with you to prepare a patent application. Generally, a patent application will be filed at the United States Patent and Trademark Office (USPTO) as a provisional application. The provisional application is not examined by the PTO but filing the application is important because it establishes a priority date for your invention against any similar applications. You should work closely with the contract attorney to make sure you fully disclose and describe all aspects of your invention and its uses in order to establish a strong foundation for patent protection.
The patent application prosecution process, from filing the provisional application through to the granting of an issued patent generally takes 3-5 years. Delays may occur when the patent prosecution is complex or situations such as patent interferences arise. Although this may seem long, the time span is beneficial, especially for early-stage technologies. Additional developments to the technology during this time period can be added to an existing patent application to strengthen the application. Also, during this time, OTT may find a licensee for the invention who may assume the payments for patent prosecution and maintenance.
Utility and plant patents issuing from the applications filed after June 7, 1995, will expire twenty (20) years from the date of filing. The terms of certain utility patents, however, may be extended to compensate for the following: 1) Delays resulting from the failure of the USPTO to examine a new application within 14 months of filing; 2) Delays caused by the USPTO's failure to issue a patent within three years from filing, unless the delay was caused by the applicant; and 3) Delays caused by the USPTO's failure to take certain office actions for more than four (4) months.
The cost of obtaining a patent depends on multiple factors, including the amount of protection desired (domestic versus foreign) and the complexity of the patent prosecution.
At the University of Louisville, the costs to obtain a patent for a particular invention may be covered by a grant (when allowable), or departmental or central administration funds.
University of Louisville investigators submit their inventions and discoveries to the University's Office of Technology Transfer (OTT) as research disclosures. OTT then reviews the research disclosures and makes the University's decision whether or not to elect title to the invention or discovery described within the disclosure. OTT then provides a written communication with the University's decision to the inventor(s) within one-hundred and twenty (120) days following receipt of the research disclosure.
The University of Louisville generally does not seek patent protection for commercially valuable research tools (e.g. knock-out mice, receptors, cell lines and antibodies) for which future therapeutic, diagnostic or preventive uses are not anticipated. However, OTT may license nonpatented biological materials and substances using nonexclusive licenses, and inventors can still receive royalties.
Some inventions and discoveries are best to remain in the public domain in order to ensure that they are freely and widely available.
For many early-stage technologies, the invention is in such an early stage that a patent application would not result in the issuance of a patent by the USPTO. In such case, OTT will encourage the inventor(s) to submit additional information to OTT when the new information is available for a reevaluation of the technology. OTT will categorize such early-stage technologies as "pending".
Inventions that ARE patented: The University will seek patent protection for the technologies that should be transferred to the private sector through licensing for further development, commercialization and distribution to the public. Often, without patent protection (hence exclusivity), commercial entities are unwilling to develop a product. The government seeks commercial partners because it is not within the scope of the government's mission to turn a discovery into a useful commercial product for wide distribution. Generally a patent is most useful when significant resources from the private sector are needed for further research and development of the technology.
[from our IP Policy]...If the decision not to invest central administration funds is made, but the central administration in conjunction with other parts of the University believes strongly in development of the Intellectual Property, the Office of Technology Transfer will work with the Creator and their College, Unit and or Department to identify alternate available University resources. If such resources are identified, the Office of Technology Transfer may also offer an option to the Creator by which the ULRF will retain ownership and provide expertise to process the Intellectual Property if the financial costs of such activity are partially or totally underwritten by non-central University funds.
Someone other than the principals directly involved in a transaction or agreement.
Public disclosure is any transfer of information about your invention, written or oral, into the public domain or to any party not obligated to keep the information confidential.
Written public disclosure does not only include published materials such as journal articles, abstracts, posters, book chapters, and proceedings. It can also encompass demonstrations, exhibits, slides, other projected material, information which is distributed or discussed at non-confidential meetings, conferences, seminars or forums, private correspondence and catalogued graduate theses. Electronic transmission of abstracts, articles or research reports is also a form of publication or public disclosure. It is also very import to note that descriptions of research projects on your departmental or faculty websites may also constitute public disclosure.
Oral public disclosure is a slightly grayer area, but it can include formal talks, meeting presentations, departmental seminars, oral theses defense and even discussions with a single person about your invention. In short, oral public disclosure encompasses any discussions where another party could take detailed notes that describe your invention.
In order to obtain the greatest scope of protection available for an invention, the invention should not be publicly disclosed to another party in an enabling manner. This means that the other party should not be able to "make" the invention after obtaining the disclosed information. It is possible to avoid public disclosure by discussing your experiments in a manner that others cannot readily duplicate. However, it is always best to contact the Office of Technology Transfer to put a Non-Disclosure Agreement in place prior to any discussions concerning your research with parties outside the University.
Grant applications to federal agencies can constitute public disclosure as they are accessible under the Freedom of Information Act. However, you can take certain steps to help maintain the confidentiality of patentable materials within the application by placing a notice on the first page of the proposal that states:
"Confidential Information - Pages ___ to ___ contain potentially patentable information."
List the pages containing the confidential information and write "CONFIDENTIAL" on each page that contains the information.
Yes, in order to maintain the confidentiality of your invention, you should contact the OTT to put a Non-Disclosure Agreement ("NDA") in place with the company prior to your discussions. If you do not have an NDA in place before discussing your invention with a company, it can constitute a public disclosure and patent rights to the invention may be lost.
The best way to protect intellectual property rights prior to public disclosure is to contact the OTT to either get an NDA in place, in the event of discussions with a company, another institution or an individual or to get a provisional patent application on file with the United States patent and Trademark Office. Please provide OTT with at least one month's prior notice of public disclosure to give us ample time to appropriately protect your invention.
Yes, public disclosure interferes significantly with patenting if you have not taken the appropriate steps to maintain your patent rights. If you publicly disclose your invention, you immediately lose most foreign patent rights. Additionally, you have only one year from the date of public disclosure to file a patent application within the United States. If you wait longer than one year, your patent rights are also lost in the United States.