Research

What About Consulting?

When researchers enter into consulting agreements, they are deemed to be acting outside of the scope of their employment. Therefore consulting arrangements are not negotiated by the University nor formally reviewed by OLV.  Researchers who enter into consulting agreements should familiarize themselves with the policies of their school or college relevant to consulting activities. The researcher is expected to ensure that the terms of the consulting arrangement are consistent with University policies, including those related to IP ownership, employment responsibilities and use of Intellectual Property. OLV is available to provide informal advice on how your consulting agreement relates to your Intellectual Property.

A discussion regarding consulting and conflict of interest can be found here.

What rights does a research sponsor have to any discoveries associated with my research?

The Sponsored Research Agreement 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 the defined and expected outcomes of the research. Often, sponsored research contracts allow the sponsor a limited time to negotiate a license for any patent or intellectual property rights developed as the result of the research. 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.

Sponsored research projects are handled by the Office of Research Contracts for the Medical School/Health System and Office of Research Support for the University. Project representatives from both these offices work closely with OLV on intellectual property issues in sponsored research agreements. If you have questions about sponsored research, please contact your project representative responsible for your unit.

Will I be able to share materials, research tools or intellectual property with others to further their research?

Yes. However 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) completed to protect your research results or intellectual property. All MTAs are handled by the Office of Research Contracts. However if you plan to discuss your invention with a third party, please contact your OLV licensing specialist to discuss whether an NDA is needed.

Will I be able to publish the results of my research and still protect the commercial value of my intellectual property?

Yes, but since patent rights are affected by these activities, it is best to submit an Invention Disclosure (discussed in next section) well before communicating or disclosing your invention to people outside the Duke community.  There are significant differences between the U.S. and other countries as to how early publication affects a potential patent. Once publicly disclosed (published or presented in some form), an invention may have restricted or minimal potential for patent protection outside of the United States. Be sure to inform the licensing specialist assigned to you of any imminent or prior presentation, lecture, poster, abstract, website description, research proposal submission, dissertation/masters thesis, publication, or other public presentation including the invention.

Invention Disclosure Form

What is the definition of an inventor on a patent and who determines this?

Under U.S. law, an inventor is a person who takes part in the conception of the ideas in the patent claims of a patent application. Thus, inventorship of a patent application may change as the patent claims are changed during prosecution of the application. An employer or person who only furnishes money to build or practice an invention is not an inventor. Inventorship is a legal issue and may require an intricate legal determination by the patent attorney prosecuting the application.

Can a student contribute to an invention?

Yes, many students work on inventions at Duke under a wide variety of circumstances. Duke promotes student entrepreneurism, and students can be named as Inventors under Duke’s Technology Transfer Policy. Typically, a student will own his or her rights to an invention unless the invention was created by a student in a capacity as a Duke employee and/or the student used more than incidental Duke resources.

Who owns rights to discoveries made while I am consulting?

The ownership of inventions made while consulting for an outside company depends on the terms of your consulting contract. It is important to clearly define the scope of work within consulting contracts to minimize any issues with ownership of inventions created from University research. If you have questions, OLV is available for informal advice.

What is “intellectual property” and who owns what I create?

Intellectual property includes inventions and/or material that may be protected under the patent, trademark and/or copyright laws, and sometimes by contract.

Ownership depends upon the employment status of the creators of the invention and their use of University facilities. Considerations include:

  • What is the source of the funds or resources used to produce the invention?
  • What was the employment status of the creators at the time the intellectual property was made?
  • What are the terms of any agreement related to the creation of the intellectual property?

As a general rule, the University owns inventions made by its employees while acting within the scope of their employment or using University resources.

The University’s copyright policy describes the applicable rules for copyrightable works. Also see relevant excerpts from the Duke Faculty Handbook here. In some cases, the terms of a Sponsored Research Agreement or Materials Transfer Agreement may impact ownership. When in doubt, it is best to call OLV for advice.

How do I submit an Invention Disclosure?

You can download a disclosure form and simple instructions from here.

Invention Disclosures are assigned weekly to an OLV licensing specialist. If you have any questions, call us at 919.681.7578 or email us at info-olv@duke.edu.

Should I disclose research tools?

Yes, if your new tools would benefit other researchers and you are interested in providing them to those researchers and other third parties. Typically, research tools are materials such as antibodies, vectors, plasmids, cell lines, mice, and other materials used as “tools” in the research process. Most research tools do not necessarily need to be protected by patents in order to be licensed to commercial third parties and/or generate revenue for your laboratory. If you have research tools that you believe to be valuable, or wish to provide to others (including research collaborators), OLV will work with you to develop the appropriate protection, licensing, and distribution strategy.

When should I complete an Invention Disclosure?

You should complete an Invention Disclosure whenever you feel you have discovered something unique with possible commercial value. This should be done well before presenting the discovery through publications, poster sessions, conferences, press releases, or other communications. Once publicly disclosed (i.e., published or presented in some form), an invention may have restricted or minimal potential for patent protection outside of the United States. Differences exist between the U.S. and other countries on the impact of early publication on a potential patent. Be sure to inform OLV of any imminent or prior presentation, lecture, poster, abstract, website description, research proposal, dissertation/masters thesis, publication, or other public presentation including the invention.

 

If you are unsure, call our office at (919)-681-7578.

How do I know if my discovery is an invention?

You are encouraged to submit an Invention Disclosure for all inventions and developments that you feel may solve a significant problem and/or have significant value. If you are in doubt, contact Duke OLV to discuss the invention and strategies for commercialization.

Why should I submit an Invention Disclosure?

When you disclose your invention to OLV, it starts a process that could lead to the protection and commercialization of your technology. This may involve beginning the legal protection process and working to identify outside development partners. If government funds were used for your research, you are required to file a prompt disclosure, which will be reported by OLV to the sponsoring agency. Similar requirements may exist for other sponsored projects.

What is an Invention Disclosure?

An Invention Disclosure Form (IDF) is a written description of your innovation or development that is provided to OLV. Your innovation can be a method of use of a substance, a composition of matter, a new device, software, or even just an idea. The IDF should list all collaborating sources of support and include all of the information necessary to begin pursuing protection, marketing, and commercialization activities.

This document will be treated as “University Confidential.” Based on the Invention Disclosure, OLV may generate a non-confidential description of your invention in order to assist in marketing the technology. Once potential partners have been identified,  and confidentiality agreements have been signed, more detailed exchanges of information can be made.

Assessment

Is an invention ever assigned to an Inventor?

If OLV 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.

How do we decide whether to commercialize with a traditional or an “open source” license for software?

Duke OLV supports the efforts of Duke researchers to share software code and research data that have been developed under federal funding with other researchers in the academic community. However, there may  be conditions that restrict or limit such dissemination, including but not limited to: third party  rights (due to presence of third party code), license compatibility (due to presence of other open source code) and even compliance (e.g. HIPAA, export control laws etc.). For code and data developed using non-federally funded research, there may be obligations to the research sponsor with regards to intellectual property rights which restrict sharing of software code and data.

Open source and open data licenses are some of the mechanisms available for researchers to disseminate software code and data to other researchers. However, if you would like retain broad commercialization rights, there are other mechanisms to disseminate your code or data within the academic community including academic software research licenses and data sharing agreements. Researchers interested in potential commercialization of software/data are advised to contact OLV’s Dinesh Divakaran to discuss available dissemination options.

If the inventors believe that all IP should be licensed non-exclusively to all potential users for the public good, will the University honor our request?

OLV will work with you to develop the appropriate commercialization strategy for the invention. Some technologies lend themselves to non-exclusive licensing (licensing to multiple third parties), while others will only reach the commercial marketplace, and therefore the public, if they are licensed on an exclusive basis. We will try to accommodate inventors’ commercialization wishes. However, the final decision will be determined by our assessment of which strategy will produce the most benefits for the general public, consistent with governmental or institutional policies and other obligations.

How does OLV assess Invention Disclosures?

Licensing Specialists at OLV 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.

Protection

What is trademark registration?

See our section on trademarks here. Trademark registration is a procedure in which the United States Patent and Trademark Office (PTO) provides a determination of rights based upon legitimate use of the mark. However, it is not necessary to register a trademark or service mark to prevent others from infringing upon the trademark. Trademarks generally become protected as soon as they are adopted by an organization and used in commerce, even before registration. With a federal trademark registration, the registrant is presumed to be entitled to use the trademark throughout the United States for the goods or services for which the trademark is registered.

Will the University initiate or continue patenting activity without an identified licensee?

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).

What if I created the invention with someone from another institution or company?

If you created the invention under a sponsored research or consulting agreement with a company, the OLV licensing specialist will need to review that contract to determine ownership and other rights associated with the contract and to determine the appropriate next steps. Should the technology be jointly owned with another academic institution, OLV will usually enter into an “inter-institutional” agreement that provides for one of the institutions to take the lead in protecting and licensing the invention, sharing of expenses associated with the patenting process and allocating any licensing revenues. If the technology is jointly owned with another company, your licensing specialist will work with the company to determine the appropriate patenting and licensing strategy.

What does it cost to file for and obtain a patent?

Filing a regular U.S. patent application may cost between $10,000 and $20,000. To obtain an issued patent may require an additional $10,000 to $15,000 for patent prosecution. Filing and obtaining issued patents in other countries may cost $25,000 or more per country. Also, once a patent is issued in the U.S or in foreign countries, certain maintenance fees are required to keep the patent alive.

Why does Duke protect some intellectual property through patenting?

Patent protection is often a requirement of a potential commercialization partner (licensee) because it can protect the commercial partner’s often sizable investment required to bring the technology to market. Due to their expense and the length of time required to obtain a patent, patent applications are not possible for all University intellectual property. We carefully review the commercial potential for an invention before investing in the patent process. However, because the need for commencing a patent filing usually precedes finding a licensee, we look for creative and cost-effective ways to seek early protections for as many promising inventions as possible.

What is the timeline of the patenting process and resulting protection?

Currently, the average U.S. utility patent application is pending for about two years, though inventors in the biotech and computer fields should plan on a longer waiting period. Once a patent is issued, it is enforceable for 20 years from the initial filing of the application that resulted in the patent, assuming that PTO-mandated maintenance fees are paid.

Is there such a thing as an international patent?

Although an international patent does not exist, an international agreement known as the Patent Cooperation Treaty (PCT) provides a streamlined filing procedure for most industrialized nations. For U.S. applicants, a PCT application is generally filed one year after the corresponding U.S. application (either provisional or regular) has been submitted. The PCT application must later be filed in the national patent office of any country in which the applicant wishes to seek patent protection, generally within 30 months of the earliest claimed filing date.

The PCT provides two advantages:

First, it delays the need to file costly foreign applications until the 30-month date, often after an applicant has the opportunity to further develop, evaluate and/or market the invention for licensing. Second, the international preliminary examination often allows an applicant to simplify the patent prosecution process by having a single examiner speak to the patentability of the claims, which can save significant costs in prosecuting foreign patent applications.

An important international treaty called the Paris Convention permits a patent application filed in a second country (or as a PCT application) to claim the benefit of the filing date of an application filed in a first country. However, pursuant to this treaty, these so-called “convention applications” must be filed in foreign countries (or as a PCT) within one year of the first filing date of the U.S. application.

What is different about foreign patent protection?

Foreign patent protection is subject to the laws of each individual country, although in a general sense the process works much the same as it does in the United States. In foreign countries, however, an inventor will lose any patent rights if he or she publicly discloses the invention prior to filing the patent application. In contrast, the United States has a one-year grace period.

What is the difference between a provisional patent application and a regular (or “utility”) patent application?

In certain circumstances, U.S. provisional patent applications can provide a tool for preserving patent rights while temporarily reducing costs. This occurs because the application is not examined or published during the year in which it is pending and claims are not required. A regular U.S. application and related foreign applications must be filed within one year of the provisional form in order to receive its early filing date. However, an applicant only receives the benefit of the earlier filing date for material that is adequately described and enabled in the provisional application. As a result, the patent attorney may need your assistance when an application is filed as a provisional.

What is the patenting process?

Patent applications are generally drafted by a patent attorney or a patent agent (a non-attorney with a science education licensed to practice by the PTO). The patent attorney generally will ask you to review an application before it is filed and will also ask you questions about inventorship of the application claims. At the time an application is filed, the patent attorney will ask the inventor(s) to sign an Inventor’s Declaration and an Assignment, which evidences the inventor’s duty to assign the patent to the University.

In about one year or longer, depending on the technology, the patent attorney will receive written notice from the PTO as to whether the application and its claims have been accepted in the form as filed. More often than not, the PTO rejects the application because either certain formalities need to be cleared up, or the claims are not patentable over the “prior art” (anything that researchers in the field have made or publicly disclosed in the past). The letter sent by the PTO is referred to as an Office Action or Official Action.

If the application is rejected, the patent attorney must file a written response, usually within three to six months. Generally the attorney may amend the claims and/or point out why the PTO’s position is incorrect. This procedure is referred to as patent prosecution. Often it will take two PTO Official Actions and two responses by the patent attorney—and sometimes more—before the application is resolved. The resolution can take the form of a PTO notice that the application is allowable; in other words, the PTO agrees to issue a patent. During this process, input from the inventor(s) is often needed to confirm the patent attorney’s understanding of the technical aspects of the invention and/or the prior art cited against the application. The PTO holds patent applications confidential until published by the PTO, 18 months after the earliest priority date.

 

Who is responsible for patenting?

OLV  has a patent attorney on staff who may work with you to file a provisional patent application as well as assist in any other issues relating to patent prosecution. Generally, OLV contracts with outside patent counsel for IP protection after provisional application filing, thus assuring access to patent specialists in diverse technology areas. Inventors work with the patent counsel in drafting the patent applications and responses to worldwide patent offices. OLV licensing specialists and our in-house attorney will help with the selection and oversight of the outside patent counsel.

What is the definition of an inventor on a patent and who determines this?

Under U.S. law, an inventor is a person who takes part in the conception of the ideas in the patent claims of a patent application. Thus, inventorship of a patent application may change as the patent claims are changed during prosecution of the application. An employer or person who only furnishes money to build or practice an invention is not an inventor. Inventorship is a legal issue and may require an intricate legal determination by the patent attorney prosecuting the application.

What is the United States Patent and Trademark Office (PTO)?

The PTO is the federal agency, organized under the Department of Commerce, that administers patents on behalf of the government. The PTO employs patent examiners skilled in all technical fields in order to appraise patent applications. The PTO also issues federal trademark registrations.

Can someone patent a naturally occurring substance?

Generally, no. A variation of a naturally occurring substance may be patentable if an inventor is able to demonstrate substantial non-obvious modifications that offer advantages of using the variant.

 

What type of subject matter can be patented?

Patentable subject matter includes processes, machines, compositions of matter, articles of manufacture, some computer programs, and methods (including methods of making compositions,  methods of making articles, and even methods of performing business).

What is a patent?

In the U.S., a patent gives the holder the right to exclude others from making, using, selling, offering to sell, and importing the patented invention. A patent does not necessarily provide the holder any affirmative right to practice a technology since it may fall under a broader patent owned by others. Instead, it provides the right to exclude others from practicing the invention.  Patent claims are the legal definition of an inventor’s protectable invention.

Marketing and Licensing

What other types of agreements and considerations apply to tech transfer?

Non-Disclosure Agreements (NDAs) are often used to protect the confidentiality of an invention during evaluation by potential licensees. NDAs also protect proprietary information of third parties that University researchers need to review in order to conduct research or evaluate research opportunities. OLV enters into NDAs for University proprietary information shared with someone outside of the University. The Office of Research Contracts and Office of Research Support handle NDAs related to research contracts.

Material Transfer Agreements (MTAs), used for incoming and outgoing materials at the University, are administered by the Office of Research Contracts. These agreements describe the terms under which University researchers and outside researchers may share materials, typically for research or evaluation purposes. Intellectual property rights can be endangered if materials are used without a proper MTA.

 

Inter-Institutional Agreements describe the terms under which two or more institutions (generally two universities) will collaborate to assess, protect, market, license, and share in the revenues received from licensing jointly owned intellectual property.

 

Option Agreements, or Option Clauses within research agreements, describe the conditions under which the University preserves the opportunity for a third party to negotiate a license for intellectual property. Option clauses are often provided in a Sponsored Research Agreement to corporate research sponsors or Option Agreements are entered into with third parties wishing to evaluate the technology prior to entering into a full license agreement.

What is the relationship between an inventor and a licensee, and how much of my time will it require?

Many licensees require the active assistance of the inventor to facilitate their commercialization efforts, at least at the early stages of development. This can range from infrequent, informal contacts to a more formal consulting relationship. Working with a new business start-up can require substantially more time, depending on your role in or with the company and your continuing role within the University. Your participation with a start-up is governed by University conflict of interest policies.

What can I expect to gain if my IP is licensed?

Per University policy, a share of any financial return from a license is provided to the inventor(s). For more information, visit Article V of the Faculty Handbook.

Most inventors enjoy the satisfaction of knowing their inventions are being deployed for the benefit of the general public. New and enhanced relationships with businesses are another outcome that can augment one’s teaching, research and consulting.  In some cases, additional sponsored research may result from the licensee.

How is a company chosen to be a licensee?

A licensee is chosen based on its ability to commercialize the technology for the benefit of the general public. Sometimes an established company with experience in similar technologies and markets is the best choice. In other cases, the focus and intensity of a start-up company is a better option. It is rare for the University to have multiple potential licensees bidding on an invention.

What is a license agreement?

License agreements describe the rights and responsibilities related to the use and exploitation of intellectual property developed at the University.  University license agreements usually stipulate that the licensee should diligently seek to bring the intellectual property into commercial use for the public good and provide a reasonable return to the University.

What is a license?

A license is a permission that the owner or controller of intellectual property grants to another party, usually under a license agreement.

Can there be more than one licensee?

Yes, an invention can be licensed to multiple licensees, either non-exclusively to several companies or exclusively to several companies, each for a unique field-of-use (application) or geography.

 

How can I assist in marketing my invention?

Your active involvement can dramatically improve the chances of matching an invention to an outside company. Your research and consulting relationships are often helpful in both identifying potential licensees and technology champions within companies. Once interested companies are identified, the inventor is the best person to describe the details of the invention and its technical advantages. The most successful tech transfer results are obtained when the inventor and the licensing professional work together as a team to market and sell the technology.

How long does it take to find a potential licensee?

It can take months and sometimes years to locate a potential licensee, depending on the attractiveness of the invention, its stage of development, competing technologies, and the size and intensity of the market. Most university inventions tend to be in the early stage in the development cycle and thus require substantial commercialization investment, making it difficult to attract a licensee.

How are most licensees found?

Studies have shown that 70% of licensees were already known to the inventors. Thus research and consulting relationships are often a valuable source for licensees. Licensees are also identified through existing relationships of OLV staff.  Our licensees often license more than one technology from the University.  We attempt to broaden these relationships through contacts obtained from website posting inquiries, market research, industry events and the cultivation of existing licensing relationships.

How does OLV market my invention?

Licensing specialists use many sources and strategies to identify potential licensees and market inventions. Sometimes existing relationships of the inventors, the OLV staff, and other researchers are useful in marketing an invention. Market research can  assist in identifying prospective licensees. We also examine other complementary technologies and agreements to assist our efforts. We use our website to post inventions, leverage conferences and industry events, and make direct contacts. Faculty publications and presentations are often excellent marketing tools as well.

Commercialize/Revenue

How is equity from a license distributed?

When University equity is liquidated the resulting funds are distributed in accordance with the RDP and University Policy.

REINVESTMENT AND RELATIONSHIPS

Every year, OLV, working with our Duke inventors and business partners:

Assists with approximately 300 invention disclosures

Negotiates over 75 option and license agreements

Assists in forming 6-10 new business start-ups

This activity generates millions of dollars in annual revenues which are shared among Duke schools and colleges, departments and units, labs, inventors and partnering institutions.  These revenues are reinvested in additional research and education, thus fostering the creation of the next generation of research, researchers and entrepreneurs.

In addition, the resultant relationships created and deepened with these activities support our University missions. They result in additional research projects, broader educational opportunities and collaborative investments, and an enhanced ability to create, retain and share valuable resources that contribute to our quality of life.

How are inventor revenues distributed if there are multiple inventors and/or multiple inventions in a license?

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. OLV 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, OLV will make the final revenue allocation decision. Please refer to OLV’s Revenue Distribution Plan page for more information.

How are license revenues distributed?

OLV is responsible for managing the expenses and revenues associated with technology agreements. Per Article V of OLV Policy on Inventions, Patents and Technology Transfer, revenues from license fees, royalties and equity—minus any unreimbursed patenting and file expenses—are shared with inventors.

What revenues are generated for the University if commercialization is successful? If unsuccessful?

Most licenses have licensing fees that can be very modest (for start-ups or situations in which the value of the license is deemed to warrant a modest license fee) or can reach hundreds of thousands of dollars. Royalties on the eventual sales of the licensed products can generate revenues, although this can take years to occur. Equity, if included in a license, can yield returns, but only if a successful equity liquidation event (public equity offering or a sale of the company) occurs. Most licenses do not yield substantial revenues.

The annual AUTM survey of U.S. universities demonstrates that less than 1% of all licenses yield over $1 million. However, the rewards of an invention reaching the market are often more significant than the financial considerations alone.

What is my role during commercialization?

Your role can vary depending on your interest and involvement, in the interest of the licensee in utilizing your services for various assignments, and any contractual obligations related to the license or any personal agreements.

 

What activities occur during commercialization?

Most licensees continue to develop an invention to enhance the technology, reduce risk, prove reliability, and satisfy the market requirements for adoption by customers. This can involve additional testing, prototyping for manufacturability, durability and integrity, and further development to improve performance and other characteristics. Documentation for training, installation and marketing is often created during this phase. Benchmarking tests are often required to demonstrate the product/service advantages and to position the product in the market.