OFFICE OF TECHNOLOGY TRANSFER (OTT) - FREQUENTLY ASKED QUESTIONS
GENERAL RESEARCH DISCLOSURE QUESTIONS:
1. If I invent something at the University of Louisville, does it belong to the University?
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.
2. Do I have to disclose my research?
Yes you should disclose any Intellectual Property. 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 either simultaneously with or prior to public disclosure.
3. What is the benefit of disclosing Research to OTT?
There are several benefits to disclosing to 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.
4. How do I disclose my Research?
The Office of Technology Transfer provides several ways for you to disclose your Intellectual Property. These include:
a. Filling out a Research Disclosure Form OR
b. Call (502) 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.
5. Who should be listed as a research?
Anyone who contributed to the inventive concepts that make the Intellectual Property different (i.e. novel) and non-obvious 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.
6. When does research become an invention?
Research becomes an invention when you have an idea and it has been reduced to practice (actual or constructive). Under U.S. patent law, an invention is defined as 1) new and useful processes, and 2) 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.
7. When is the right time to submit a disclosure? Is proof of concept necessary?
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 either simultaneously with or prior to a public disclosure such as submitting an abstract for a scientific meeting or submitting a manuscript.
Proof of Concept concerns demonstrating that the Intellectual Property will work and 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. Funding for Proof of Concept work is available from the University of Louisville.
8. Once the research is disclosed, what is the evaluation process to determine whether or not it is an invention with commercial potential?
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.
9. Why do you ask what funding source I have?
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.
10. Why does it matter if I have a VA appointment?
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.
MATERIAL TRANSFER AGREEMENT (MTA):
1. What is an MTA?
A Materials Transfer Agreement (MTA) is the contractual instrument used to define the terms and conditions for the exchange of materials. While MTA's are not funding agreements, many of the issues usually associated with a research contract can apply to these transfers and can have a dramatic impact on future research efforts. An MTA typically sets forth rights to use the materials and may allocate rights that result from their use. Often MTA's address such issues as publication, involvement of students, 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.
2. When is an MTA necessary?
MTA's are necessary any time a researcher at the University wishes to send or receive materials of a confidential or proprietary nature; material that is infectious, hazardous or subject to special regulations; material for which the provider is concerned about potential liability; or material for which the provider wishes to obtain rights to the results of the research in which the material or information is to be used.
3. Which MTA terms are always problematic for the University?
Several terms that are common in MTA's are problematic for the University. Terms setting governing law to a jurisdiction other than Kentucky and terms requiring the University to indemnify the other party will always require negotiation. Likewise, terms that restrict publication and academic freedom are subject to strict scrutiny. Any such terms found to be overly restrictive are also unacceptable. In addition, terms that assert excessive ownership rights in the research results or in intellectual property generated by the research are problematic.
4. Who has the authority to sign an MTA?
The Office of the Executive Vice President for Research has several authorized signatories for signing MTA's. The primary signatories are the Director and the Deputy Director of the Office of Technology Transfer.
Many MTA's ask for the researcher to sign the MTA. This is acceptable, if the signature is to confirm that the researcher has read and understood the terms of the MTA. However, MTA's are agreements between the University and the Provider or Recipient - the researcher is not a party to the agreement. As the University is the party to the agreement, only individuals authorized to sign such agreements on behalf of the University have the authority to bind the University to an MTA.
5. What happens if someone without authority signs the MTA?
In the worst case scenario, the unauthorized signatory would be held personally bound to the terms of the agreement. Most likely, when the unauthorized signature is discovered, the OTT will have to notify the other party, and then proceed with negotiations to arrive at an agreement that can be signed by the University.
6. What is the UBMTA?
The Uniform Biological Material Transfer Agreement (UBMTA) was developed by the Association of University Technology Managers (AUTM), in conjunction with the National Institutes of Health and the Centers for Disease Control, to facilitate transfers of materials between NIH-funding researchers and, more generally, for transfers between academic institutions. Institutions that are a signatory to the Master Agreement are able to transfer materials under the terms of the UBMTA simply by sending a simple letter agreement.
7. Are there any alternatives to using an MTA?
For materials that are commercially available, the option of purchasing those materials may be considered. Sometimes, obtaining a material through a MTA will be problematic, but purchasing the material will bypass the issues. At other times, pursuing sponsored research with a company will be a viable alternative to a MTA.
8. Are there special requirements for human tissue transfers?
First, in order to transfer human tissues, the consent form used to gather those tissues must allow for the transfer of such tissue. Checking with the IRB to be certain of this is absolutely important. In the event the consent form does not provide for the transfer of tissues collected, the IRB can assist in exploring alternatives.
Second, the tissues must be transferred with no identifying information, or a Data Use Agreement must be negotiated, in order to allow a limited data set to be transferred. Also, the authorization obtained prior to collection may provide the ability to transfer. The Privacy Office can assist you in this determination.
9. Are there special requirements for toxic material transfers?
For the transfer of materials that are toxic or otherwise classified has hazardous, please contact UofL's biological Safety Office, Dr. Carol Whetstone, or her assistant, Stacy Hart, Biological Safety Specialist. Authorization from their office will need to be obtained before a MTA dealing with such material can be fully processed.
1. What is a patent?
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:
- a.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;
- b. Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and
- c. Plant patens may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.
2. Who is an inventor?
An inventor is the "idea" person who has the creative concepts that make the invention new and non-obvious (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).
3. What are the legal requirements for a patent?
A patentable invention must be something new, useful and non-obvious, 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 non-obvious 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.
4. Who prepares and prosecutes patent applications?
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.
5. How long does it take to obtain a patent?
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.
6. How long does patent protection last?
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.
7. What is the cost of obtaining a patent?
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.
8. Who pays for the patent?
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.
9. Who decides whether or not to file patent applications?
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.
10. Why are some inventions not patented?
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 non-patented 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.
11. What happens if OTT decides not to file a patent on my invention?
[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.
TALKING TO THIRD PARTIES AND PUBLIC DISCLOSURE
1. What is consider a third party?
Someone other than the principals directly involved in a transaction or agreement.
2. What is considered public disclosure?
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 cataloged 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 disclosureis 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.
3. Is a Grant Proposal considered public disclosure?
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.
4. Should I contact OTT before talking to a company about my invention?
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.
5. How do I protect intellectual property rights before public disclosure?
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.
6. Does public disclosure interfere with patenting?
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.
START-UP COMPANIES AND LICENSING TECHNOLOGIES:
Answers to these questions coming soon
1. What is the role of OTT in commercializing university Research?
2. How is my invention marketed or licensed?
3. Can I start a company around an invention I made at UofL?
4. Can OTT help me start a company?
Answers to these questions coming soon
1. How is the license income distributed to employees (faculty and staff)?
2. How is the license income distributed to colleges and departments?
3. Can my license income be applied to patent reimbursement costs?