Overview of technology commercialization
The phrase “technology commercialization” is similar to “technology transfer” and, in the context of an academic institution, generally refers to the process of protecting and subsequent licensing of intellectual property rights to third parties, such as private corporations, for the purpose of continued research and/or development of a commercial product. Intellectual property rights generally include patents, copyrights, trademarks, service marks, mask works, and trade secrets. The technology transfer process begins with an Invention Disclosure Form submission to the OTC and, for patentable subject matter, proceeds through the stages of review and evaluation, patent prosecution if appropriate, marketing to prospective licensees, engaging in the license negotiations, and monitoring any subsequent licenses or contracts.
Inventions and Inventorship
- What agency governs what is patentable and issues patents in the U.S.? Copyrights?
The United States Patent and Trademark Office handles patent applications, their review, and issuance of patents and related activities, as well as trademarks and related matters. Copyright matters are handled by the US Copyright Office.
- How do I disclose my invention to the OTC?
An Invention Disclosure Form (IDF) must be completed, signed and submitted to the OTC. You may file your IDF online via this link.
- What is an Invention Disclosure Form?
An Invention Disclosure Form (IDF) is a document that summarizes all pertinent information regarding your invention. By submitting a signed IDF to OTC, you create a formal record of the invention that includes the description of the invention, the names of the investigators who may be the inventor(s), any organizations that sponsored the work, any public disclosures and/or publications that may have been made, and other pertinent information. This formal record is required for entering your invention into OTC’s database. The case manager assigned to your technology uses the information in the IDF, along with discussions with inventors, as a basis for determining whether a patent should be filed.
- Do I have to disclose my invention to OTC?
Employees and other Covered Individuals of Georgetown University are obligated to fully disclose any invention made or conceived during an assignment pursuant to a research project, grant, contract, or any other university-administered program and any invention that was made or conceived using the university’s facilities, equipment, funds, or other contributions.
Furthermore, University inventors must identify all potential co-inventors, disclose potential conflicts of interest, and execute all necessary contracts, assignments, waivers, disclosures, or other necessary legal documents. These obligations persist even after inventors leave the university.
For further information, please consult the University’s Faculty Handbook.
- When should I submit my IDF?
To allow enough time for thorough review, evaluation, and patenting, the IDF or at least a description of the technology (even if all the supporting data are not yet available) should be submitted as soon as you think you may have an invention and no less than two to three months in advance of the first publication or other public disclosure of the invention.
- What if I have improved an invention that was already disclosed to the OTC?
An improvement to an invention may constitute a separately patentable invention or maybe an important supplement to a previously filed patent application. The new information should be submitted to the OTC through a new IDF.
- What is public disclosure, and why is it important?
A public disclosure is any disclosure of the invention in which persons other than Georgetown personnel may hear or read about the invention. Disclosures can be conference presentation abstracts, journal publications, graduate student dissertations and/or theses, meeting and poster presentations, presentations to prospective funding organizations (including companies and individuals), descriptions of your research on websites (including your own or your department’s website), press releases, and news articles. Importantly, public disclosure can prevent the University from obtaining patent protection for your invention abroad and may compromise US patentability under certain circumstances. Public disclosures occur when the audience or recipient of the information has not already agreed in writing to hold the information in confidence.
University inventors should contact the OTC before describing the invention to anyone outside the University. Even describing your invention in an academic setting for educational purposes may still compromise the ability to obtain a patent if anyone in the audience is not subject to the University’s policies.
If you have any questions or concerns about whether an activity may constitute a public disclosure, please contact the OTC.
- What does “first-to-file” mean?
Before March 16, 2013 (when the relevant aspects of the “America Invents Act” went into effect), an inventor (Inventor A) who filed a patent application in the U.S. could receive a patent application, even if another inventor (Inventor B) filed on essentially the same invention earlier, as long as Inventor A could demonstrate with written evidence to the USPTO that he/she had the invention in hand before Inventor B filed. On March 16, 2013 the law changed such that only the first inventor to file could receive a patent, bringing the U.S. in line with the rest of the world regarding “first (inventor)-to-file.”
- What constitutes an “invention”?
Whether or not an “invention” has been made depends on whether or not there has been a “conception.” Conception is the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is to be applied in practice. Conception is established when the invention is made sufficiently clear to enable one “skilled in the art” to reduce it to practice without extensive experimentation or inventive skill.
- What makes an invention “patentable”?
For an invention to qualify for a patent, the invention must be novel, non-obvious, and useful. Inventions may be devices, articles, or reagents that can be manufactured, compositions of matter, methods of use, or new and useful improvements of existing inventions.
Utility: The invention must be useful and good for some applied purpose.
Novelty: The invention must be new, i.e., the exact same thing must not have existed or been done before.
Non-Obviousness: Even if novel, the invention must also be different enough from past technology that the average worker in the field (“skilled in the art”) would not have come up with the new invention from what was already known. If the invention does not meet this test, it is rejected as obvious.
- Who is considered an “inventor”?
Inventorship in the U.S. is a legal standard established by the USPTO. Co-authors on journal articles or manuscripts are not necessarily co-inventors of an invention related to or disclosed in the article. According to the USPTO, the threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the invention’s conception, he/she is not an inventor. With regard to the inventorship of chemical compounds, an inventor must have a conception of the specific compounds being claimed. Regarding joint inventorship, named inventors must each contribute to at least one of the issued claims, and co-inventors must generally each be involved in the conception of the invention and have some degree of collaboration on the inventive work. An individual suggesting an idea of a result to be accomplished rather than the means of accomplishing it or someone who has simply followed instructions in reducing the invention to practice, for example, is not a co-inventor.
The Patent Prosecution Process
1. What is Patent Protection?
Patents are intended to reward an inventor for publicly disclosing an invention by granting the inventor the right, for a limited time, to exclude others from practicing the invention (from making, using, selling, offering to sell, and importing the patented invention). However, a patent does not grant the right to practice the invention or guarantee that a marketable product or service may result. Therefore, in determining whether to seek patent protection for university inventions, the OTC looks beyond the technical merits of an invention and the likelihood of successfully obtaining a patent towards the existing or future market(s) for the invention, including the size of the market and competition within the market and assesses and determines whether there is a reasonable expectation of producing a marketable product or service using the technology.
The OTC, on behalf of Georgetown University, is responsible for determining whether to pursue patent protection and, if the OTC deems it appropriate, to collaborate with both the inventors and patent professionals to ensure quality patent protection.
2. What is prior art?
Prior art is relevant past technology that the patent office may consider in evaluating novelty and non-obviousness. Anything that has been published, used in the public domain, offered for sale, sold by anyone before the inventor(s) made the invention, or otherwise made publicly available before the application is filed becomes a part of the prior art for a patent application filed in the U.S. The inventor’s own publications made within a year before the filing of the patent application do not prevent the inventor from obtaining a patent. However, such publications do prevent most foreign patents from being obtained because of the different requirements for absolute novelty among other countries.
3. What is a provisional patent application, and why file one?
The provisional patent application is an application that can be filed with the USPTO that establishes the effective filing date (priority date) of a patent application. The provisional application has a term of only twelve months. At the end of the twelve-month period, the University must elect to either abandon the filing or convert the provisional application to a nonprovisional (utility) patent application. If the provisional filing is abandoned, any information in the public domain after that filing can become prior art to future filings. The USPTO does not examine provisional patent applications, and the patent prosecution process begins at the patent office once a utility application has been filed.
In addition to establishing the filing date and being lower-cost, the provisional application provides inventors with a twelve-month block of time to conduct additional research and further develop the invention, and possibly acquire funding. It also gives the OTC additional time to determine marketability and the opportunity to seek licensees before deciding whether to convert the application to a utility patent application, accruing additional expenses and commitment.
4. What does it cost to file and prosecute a patent?
Typically, the cost of preparing (filing) a complete patent application in the U.S. is between $6,000 and $10,000, depending on the complexity of the application. Prosecution of the application (the review process by the patent office involving rejection or acceptance of claims and the University’s responses to those judgments before decision on allowance) can increase the total cost to $25,000 or more in the U.S. and up to $100,000 or more abroad, depending on the number of countries in which the application has been filed.
5. What is a Declaration?
A Declaration is an oath that the applicant makes in which the inventor(s) states that inventor(s) believes himself/herself to be the original inventor (or joint inventor) of the invention for which the University is seeking a patent; it also names the inventor’s country of citizenship.
6. What is Power of Attorney (POA)?
The University itself does not prosecute patent matters before the U.S. or foreign patent offices – it engages outside counsel to act on its behalf in such matters. The University formally gives such outside law firms the right to do so through power attorney, effected in a formal document that allows a registered patent attorney or patent agent to sign documents on the University’s behalf and practice before the USPTO (or foreign offices) as an authorized representative of Georgetown University.
7. What is an assignment?
An assignment is a written document that transfers rights or interests in a patent or patent application from one party to another. In the U.S., the assignment must be notarized to be valid. Similar requirements of certification are required in foreign countries.
8. Why do I have to assign my invention to Georgetown University?
According to Georgetown University policy, all inventions conceived and/or reduced to practice at Georgetown University by Georgetown Covered Individuals (as defined in the Faculty Handbook and the Georgetown University Intellectual Property Policy) are owned by the University through assignment from the inventor(s). Generally, assignable inventions are made by Covered Individuals during a research project, grant, contract, or any other University administered program or utilizing facilities, equipment, funds, or other contributions of the University, provided that the University has not entered into a research grant or contract agreement with expressed provisions to the contrary. Inventions made by a Covered Individual exclusively on his/her own time, unrelated to his/her University obligations, and without the aid of any Georgetown University resources are the sole property of the Inventor. Click here to download a copy of the Georgetown University Intellectual Property Policy.
9. What happens if I move to another university or institution?
If your invention was conceived or reduced to practice at Georgetown, the invention remains the property of Georgetown. You may be asked to review your research portfolio with the OTC to determine if an Invention Disclosure must be filed at Georgetown before departure. According to Georgetown policy, any royalties or payments resulting from commercialized patents or other Intellectual Property to which you would be entitled would continue to be disbursed to you.
10. Who owns what I invent there if I go on sabbatical or elsewhere to work while still employed at Georgetown?
Generally, these situations are governed by existing policies at the home institution and the host institution – however, that often creates a conflict of ownership, as both may likely claim ownership. In some cases, ownership is determined by which institution pays the investigator’s salary during the sabbatical. It is prudent to contact the OTC before such sabbaticals so that we can assist in sorting out the rights and responsibilities that belong to each institution and to the investigator. An agreement that stipulates intellectual property ownership may be required. If you have been given such an agreement before your sabbatical, please discuss it with the OTC before your departure.
11. Whom do I contact if I need a copy of my patent application?
You may contact Silvana Alcocer at 202-687-0843 or the licensing manager who worked with the law firm and you during the prosecution.
Technology Transfer and Other Agreements
1. Why do I need to have an MTA or (other similar documents) to transfer materials or samples?
Material Transfer Agreements (MTAs) are legal contracts that provide a chain of custody record and the framework for using transferred materials appropriately. Many providers and recipients of materials want to have written agreements to ensure a common understanding of how the materials may be used and what rights may or may not be attached to the materials or inventions made using the materials. If the materials being transferred are of human origin, references to IRB approval and necessary handling restrictions may also need to be included. MTAs and similar agreements are managed and signed by OTC. The University (OTC) is the signatory on these agreements, and Principal Investigators are not authorized to sign the agreement on behalf of the University, although they may be asked to sign a “Read and Acknowledged” line to indicate that they are familiar with the terms and obligations of the agreement. Agreements akin to MTAs are Tissue Transfer and Biological Materials Transfer Agreements.
2. What is a Data Use Agreement?
A Data Use Agreement (DUA) is a license to transfer certain data that has been collected or developed by nonprofit, government, or private industry, where the data is nonpublic or otherwise subject to restrictions on its use and disclosure. The data may be a necessary component of a research project and may or may not constitute Protected Health Information from human subject data derived from a clinical trial, such as a Limited Data Set as defined in HIPAA. Universities endeavor to ensure that DUA terms protect the use and confidentiality of such data while promoting the parties’ rights to appropriately publish and share research results from the use of such data in accordance with University policies, applicable laws and regulations, and federal requirements. The OTC reviews, drafts, negotiates and signs Data Use Agreements for the University.
3. What is a Research Collaboration Agreement, and how is it different from a Sponsored Research Agreement?
A Research Collaboration Agreement (RCA) is an agreement entered into between two or more non-profit, governmental, or private industry parties engaged in a mutually beneficial research project. The RCA delineates the working relationship between the parties, specifying the parties’ intent to share data, research materials, and/or facilities, as applicable, and to publish research findings jointly. It is common for each party to the RCA to fund its own portion of the research project, although, in some instances, one party may cover certain expenses of another party. RCAs are drafted, reviewed, negotiated when necessary, and signed by the OTC. It is beneficial to have an RCA in place before commencing the research so that for filed U.S. patents, information exchanged between parties before the filing may be prevented from becoming prior art to the filing.
4. Why do some MTAs take longer to obtain than others?
Occasionally, proposed agreements attempt to limit an academic scientist’s freedom to carry out future work, exert excessive rights of ownership, or place investigators and the university at other unnecessary legal risks. If the provisions in the proposed agreement conflict with the University’s academic missions or create unnecessary risk, the University must try to remove the conflict by changing such terms. Some agreements can be executed within several days, such as the UBMTA (Uniform Biological Material Transfer Agreement), to which most universities subscribe. Other agreements, particularly those involving for-profit organizations, may take longer.
While OTC strives to negotiate and execute MTAs as fast as possible, extenuating circumstances may delay execution. Such matters may include conflicts of interest, the complexity or appropriateness of the agreement (sometimes an MTA is not the appropriate agreement), the determination of encumbered intellectual property (e.g. does a party other than the University already hold rights to the material?), the possible unwillingness of a provider to negotiate a mutually beneficial agreement, the timeliness of a party’s negotiation and signatory responses. OTC attempts to keep an open communication with the investigator regarding any hold-ups.
5. What is a confidentiality agreement?
A Confidentiality Agreement or Confidential Disclosure Agreement (CDA), or Non-disclosure Agreement (NDA) is a legal contract in which one party agrees to hold the other party’s proprietary technical and/or business information in confidence. Agreements may be unilateral or “one-way,” meaning confidential information will flow only from one party to the other, and the recipient is the only one with the obligation to hold the information in confidence; or they may be mutual, “two-way,” or bi-lateral, meaning that the flow of information may be in either direction and each party will keep the other’s information in confidence. CDAs or NDAs are generally routine, and many companies are amenable to having access to technology under the terms of this type of agreement. The OTC handles any CDAs involving University intellectual property, proprietary business information, and/or research. The Vice President for Technology Commercialization or another appropriate senior University official must sign these agreements on behalf of the University. Principal Investigators are not authorized to sign such agreements on behalf of the University, although they may be asked to sign a “Read and Acknowledged” line to indicate that they are familiar with the terms and obligations of the agreement.
1. What is a copyright?
Copyright is a form of protection provided by the U.S. Constitution and granted by law for original works of authorship fixed in a tangible medium of expression. It applies to literary, dramatic, musical, and artistic works, including poetry, novels, movies, songs, computer software, and architecture. This protection is available for both published and unpublished works. Copyright does not protect facts, ideas, systems, or methods of operation, but it may protect how these things are expressed. Copyrightable works come under copyright protection the moment they are created and fixed in a tangible form or performed; that is the point at which the creator holds the copyright.
The owner of the copyright generally has the exclusive right (and can authorize other to have the same rights) to reproduce works, prepare derivatives of the work, distribute copies, and perform or display the work.
2. What is the doctrine of “fair use”?
Fair use is a legal doctrine (Section 107 of the Copyright Act of 1972) that permits certain uses of copyrighted material without the copyright holder’s express permission. Section 107 calls for consideration of the following four factors in evaluating a question of fair use: purpose and character of the use; nature of the copyrighted work; amount and substantiality of what would be used from the copyrighted work; and the effect upon the work’s value.
Examples of fair use under U.S. law include scholarship and research, commentary, search engines (data and text mining), criticism, parody, and news reporting.
For more information on fair use, see here.
3. What is “work made for hire?”
When a work is created in fixed form, the copyright immediately becomes the property of the author who created the work, and only the author (or those deriving their rights through the author) can rightfully claim copyright. Once exception to this rule is works made for hire. For such works, the employer and not the creator is considered the copyright’s author and owner. Section 101 of the Copyright Law defines a work made for hire as a work prepared by an employee within the scope of his or her employment or a work specially ordered or commissioned for use, such as a contribution to a collective work, a part of a motion picture or other audiovisual work, a translation, a compilation, an instructional text, an atlas, a test or study materials if the parties expressly and mutually agree in writing that the work shall be considered a work made for hire.
4. Who owns the IP rights to my works of authorship?
Unlike other forms of intellectual property made by University employees or other persons using substantial University resources, the University generally does not require assignment of traditional scholarly works (written or edited works such as books, manuscripts, artistic works, movies, and television programs). When the University contributes more-than-usual support for creating copyrightable material or commercially valuable collections of information, the University may require the authors to collaborate with the OTC to administer an arrangement resulting in an equitable distribution of rights, responsibilities, and prospective revenues related to the work. Most published works written by faculty members have been viewed as property of the author and are published under agreements made by those authors without the participation of the University.
5. Software, Digital Resources and Collections of Information – Who Owns Copyright?
Distinctions that once were common between texts intended to convey information (which traditionally have been subject to copyright protection) and research tools (which are potentially subject to patent protection) have become less tenable at a time when software is both copyrightable and potentially patentable, and when courseware, digital academic resources, and collections of information are characterized by a high degree of interactivity. Software development by Covered Individuals frequently receives extensive support from the University. Similarly, digital resources for teaching and learning – including interactive teaching and classroom management tools, Web pages programmed in native HTML, XML or similar protocols, and media-intensive materials, including video and animation and digital content materials designed for display and dissemination over the Internet or over the University’s own network — frequently are based upon the work of many individuals (including instructional designers and technical staff) and may depend upon the University’s network and computer systems and the staff who support those systems. The creation and maintenance of collections of information, such as large databases, also frequently require extensive technical, staff, and systems support from the University.
In order to encourage the development of technology-based instructional materials, the University may choose not to exercise its claim to such works and instead to either share rights or consider the copyright to lie with the creator(s). In such cases, formal agreements between the creator(s) and the University are required per the Intellectual Property Policy. To determine whether something you created falls into this category, speak with OTC.
6. What are my obligations when I publish my scholarly works of authorship?
The University encourages authors to retain copyrights when possible, and to seek to preserve their rights to attribution on re-use of works and to disseminate their works without publishers’ permission. Ways to help maximize access to scholarly works include allowing only first publication rights to publishers, using creative commons license or open access publication options.
7. How do I give notice of copyright?
Use of copyright notice is no longer required by law, but it’s use may still be helpful. The form of the copyright notice used for “visually perceptible” copies–that is, copies that can be seen or read, either directly (such as books) or with the aid of a machine (such as films)–differs from the form used for digital materials. The notice for visually perceptible copies should contain all three elements described below. They should appear together or in close proximity on the copies.
1. The symbol (C) (letter C in a circle); the word “Copyright”; or the abbreviation “Copr.”
2. The year of first publication.
3. The name of the copyright owner.
Example (c) 2016 Jane Doe
Negotiating with Publishers – Your Rights as an Author of Scholarly Works
The University strongly encourages faculty members who publish traditional scholarly works to become familiar with their rights under copyright law and to negotiate contracts with publishers that preserve rather than waive these rights. Remember, generally, you are the owner of your scholarly works, and therefore, you control how the works may be used and distributed unless you transfer those rights in a contract, for example, with a publisher.
When negotiating with a publisher, consider checking for a template author’s agreement on their website to inform you about the kind of agreement they require. If not available on
the net, call the publisher directly. Keep an eye out for terms that describe how you may use your article after they publish it. It is possible that you may need the publisher’s permission to use your published work even in the courses you teach.
The University will seek to make available the scholarly work of faculty on institutional servers in a manner consonant with copyright law and encourage faculty to negotiate terms with publishers that allow access for academic purposes. See the Copyright section under these FAQs to understand the rights associated with copyrighted works. When negotiating with publishers, consider creating an “author’s addendum” in which you specify the rights you wish to retain or that you wish the publisher to comply with (see the SPARC Author Addendum). See also here and here.
Marketing and Licensing
The OTC is responsible for identifying potential commercial licensees, marketing University technologies, and administering and maintaining all agreements necessary to establish licensing relationships. Inventors may not independently market or license University IP but are encouraged to collaborate with the OTC to identify commercial licensees and partners and establish strong relationships with them.
1. What is a license?
A license is a legally binding written document in which one party (licensor) that has definable intellectual property rights transfers or grants all or some part of those rights to another party (licensee) for some type of consideration including royalties, license maintenance fees, milestone payments, and/or equity. The license includes terms and provisions describing the property being licensed, the specific rights being granted, the form of compensation for the transfer of rights, the limits and obligations imposed on the licensee, and diligence requirements proving the licensee is pursuing the commercialization of the intellectual property.
2. Can the OTC license my invention to more than a single third party?
Yes. A license can be “exclusive” and permit only one additional third party to practice the invention, or a license can be “non-exclusive,” permitting multiple third parties to practice the same invention. Licenses may also be drafted to grant permission for practicing the invention in a particular field of use, a particular amount of time (only a portion of the twenty-year patent term, for example), or within a specific geography. Therefore, an invention may be licensed to multiple third parties, so each third party has an exclusive license to practice the invention in a particular way. In those scenarios, the licensed uses do not overlap with one another.
3. If royalties or revenues are generated through the commercialization of my invention, how are they distributed?
The distribution of any royalties or revenues that may result from the commercialization of your invention will be governed by Georgetown University’s Intellectual Property policies as reflected in its Faculty Handbook. (See the Faculty Handbook).
4. What is socially responsible licensing?
The aim of socially responsible licensing is to facilitate the availability of innovations in health care and other fields to address society’s inadequately met and often urgent needs. Such needs may include vaccines, therapeutics, or diagnostics for neglected or emerging diseases; technological solutions to environmental issues, such as water purification; or agricultural challenges, including crop disease resistance or drought; or inadequate electronics and digital solutions for economic growth and stability. Terms that facilitate such access may include lower fees and royalties from sales in certain geographical areas or among certain populations. When a Covered Invention embodies such an innovation, the University will aim to make such innovations accessible to populations in need while balancing that need with the financial concerns of the University and the rights of Inventors about license revenues under the University IP Policy.
Even in the First-Inventor-to-File world of patents, when there is no longer the option to prove you were the first to invent something by showing your data, it is critical to keep up-to-date and thorough notebooks for several reasons.
Information kept in notebooks is still important in actions before the U.S. Patent and Trademark Office (USPTO) or courts of law, for example, to:
- Provide evidence to establish the correct inventorship of a patent.
- Prove that the invention wasn’t derived or procured from a third party.
- Establish the rights to a trade secret.
- Provide additional data to support a patent application.
Notebooks may be electronic or hardcopy. When they are hardcopy, the following
best practices should be maintained:
- Make entries in permanent ink (don’t use a pencil).
- Be detailed and thorough, including your thoughts, comments, protocols, and data.
- Keep data in chronological order and sequentially number pages.
- Sign, date, and witness, if possible, each page as soon as possible (ideally daily)
- Use a bound notebook, not loose-leaf or perforated pages. The witness should be “credible” – they should work for the University, not be a co-inventor, but be able to read and understand the work they are witnessing.
- Keep all pages in the notebook and in tact – strike out any changes, do not remove pages.
- Physically attach copies of spectral and other data and sign across the attachment and onto the page, if possible.
- Securely store the notebook.
For electronic notebooks:
- Make sure the program you use is specifically designed for record keeping.
- Have a consistent process for entering data, signing the entries, and having the “pages” witnessed.
- Have a consistent process for regular data backup and use an established procedure to prevent data from being changed inadvertently or intentionally at a later date.
- The electronic data should be stored securely, preferably at a location remote from the laboratory.
What do I need to do if I want to start a company that focuses on my invention?
For guidance on startup companies, please see the section “Supporting Entrepreneurship” under “For Inventors” elsewhere on this website.