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Additional DI Resources

DI Resources

Protection Strategies

Digital Innovations can be protected under different types of intellectual property laws. Databases may have limited protection under copyright law as a compilation.

Copyrights protect the literal expression of a creative work (e.g., a computer program).  They do not, however, protect the underlying inventive idea or discovery (e.g., the processes, methods of using, etc.) underlying the computer program, which could have considerable commercial value. These ideas and discoveries are protectable under patent law.  The patentability of software is a tricky subject as the variations from country to country are less than clear.

US: In the US, patent-eligible subject matter is defined as “any new and useful process, machine, manufacture, or composition of matter.”  Patent ineligible subject matter includes laws of nature, natural phenomena, abstract idea, and other judicial exceptions.   Recent developments in U.S. law have limited the scope of eligibility for software patents because they tend to contain abstract ideas but there are certain types of software that, when incorporated in a computer/network or a device or a machine/apparatus for technical purposes functions like control, visualization, monitoring, communications, security etc. may be patent eligible. 

China: On April 1, 2017, the State Intellectual Property Office (SIPO) revised their software patent guidelines.  The revised rules include patent eligibility for computer software and business method patents.   For example, software claims relating to “a machine-readable medium”, “a computer program product”, and “an apparatus comprising a processor configured to execute instructions on a computer-readable medium to perform steps” are now considered patent eligible.  Claims involving business methods are no longer excluded if they contain technical features.

Europe: Europe allows the for the patenting of certain kinds of software so long as they meet certain requirements.  The software must have novelty, inventive step, and industrial application.  Under the EPC, a computer program per se is not a patentable invention.  However, should the patent solve a technical problem in a novel and non-obvious manner, then it may be patent eligible.

A work that meets the criteria for a copyright (minimum creativity; originality) is copyright protected the moment it is created and fixed in a tangible form that is perceptible either directly or with the aid of a machine or device.  In general, registration is voluntary and relatively inexpensive. However, in order to bring a lawsuit for infringement of a U.S. work, you will need to have the copyright registered.  Registration offers several advantages, such as the possible recovery of statutory damages and attorney’s fees in successful litigation.

A copyright notice is an identifier placed on copies of the work to inform the world of copyright ownership.  The copyright notice generally consists of the symbol “©” or word “copyright” or “copr,” the name of the copyright owner, and the year of first publication (e.g., © 2018, Duke University. All Rights Reserved).  

There could be other forms of intellectual property rights associated with Digital Innovations beyond copyrights and patent rights. Digital Innovations such as software and databases are protectable under trade secret law. Databases in Europe could also be protectable under EU Database Rights laws beyond copyright laws.

Screen Materials like GUI’s may be protectable under Design Patents and in limited circumstances under Trade dress. Spreadsheets may be protectable under data rights that could be enforced through contracts.

Digital Innovations such software and databases are protectable under trade secret law, any non-public information that is treated as a secret and that provides a person or entity with a competitive advantage. Unlike copyrights, patents and other forms of intellectual property protection, trade secrets do not have an expiration date.

A trade secret may survive for as long as it remains secret. However, unlike private corporations, universities generally do not hold or possess trade secrets given the mission of promoting the free and public dissemination of knowledge. Trade secrets can also conflict with federal funding agencies mandates to broadly disseminate the results, data, and information that arise from the work performed utilizing federal funds. Thus, using trade secret laws to protect digital innovation in universities is not very feasible.

A trademark grants the owner the exclusive use of a word, name, or symbol (mark) to describe a product and distinguish it from other products in the marketplace. Trademarks can protect the name of a software company, its products and taglines, and prevent competitors from using similar names. Trademarks protect software brands, but not the software (or code) or database itself (or underlying data).

Ownership in DI

Inventions and associated Patent Rights in Digital Innovation are governed by Duke’s Intellectual Property Policy. If the Digital Innovation was funded under federal grant money, ownership of patent rights associated with the invention vests with Duke under the Bayh Dole Act.

As regards copyrights and other intellectual property rights (excluding patent rights), notwithstanding the general principles respecting individual ownership expressed in Duke’s copyright policy, ownership of such intellectual property rights arising in certain categories of academic works (i.e., works primarily related to the teaching or research missions of the university) listed below shall vest (as works for hire or the equivalent) in Duke:

  • Works supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke.
  • Works supported by grants, extraordinary allowance or subventions (whether in money or money’s worth, and whether or not supported by outside sources under contract), when designated as such in advance by the University.
  • Databases and similar collections of information which are obtained primarily on behalf of schools or departments rather than individuals, or which involve issues of privacy (as in the case of medical patients or identifiable human subjects) or require approval by the University’s Institutional Review Board.
  • Computer programs, when the programs are primarily created to perform utilitarian tasks.
  • Collaborative works by persons working as members of the Duke community, when numerous individual original contributions are indistinctly merged, as a practical matter, into a new and distinct work fixed in a tangible medium of embodiment, and the individual creators have not entered into an agreement with respect to joint authorship.

Duke employees include faculty, staff, researchers, clinicians, post-doctoral fellows, graduate students and undergraduate students who (1) receive a salary from Duke and/or (2) are working under a third party contract (e.g., Federal Funding). Under U.S. copyright law, generally, a copyrightable work (which includes computer programs, databases, screen materials and creative works) created by an employee within the scope of his or her employment is a work made for hire.

The employer for whom the work is made is the “author” of the work for copyright purposes and is also the owner of the work’s copyright. Unless the parties have agreed otherwise in a signed written document, the employer or hiring party owns the copyright of a work made for hire.

Ownership of intellectual property rights (patent rights, copyrights etc.) associated with Digital Innovations (software, databases, screen materials, creative works etc.) supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke according to Duke IP/Copyright policies or laws/regulations.

For example, when a federal grant (NIH, NSF, DARPA, etc) is received and administered by Duke University and its affiliates, ownership of intellectual property rights including patent rights (under the Bayh Dole Act) and copyrights generally (under OMB Circular A-110) are assigned to the grantee i.e. Duke University.

If you are Duke undergraduate student who is developing a digital innovation and is

  • (i) not being paid a salary by Duke, or
  • (ii) not using substantial Duke resources (beyond standard resources provided to all Duke students like computers or cloud space etc.) or
  • (iii) not using funds awarded/administered by Duke or other Third Party or,
  • (iv) collaborating with Duke employees (faculty, staff and even Duke students employed by Duke) in the Digital Innovation development process,

then you would own all the IP rights associated with your contribution towards developing the digital innovation.

If you are a student employed by Duke, then Duke could assert ownership to the IP rights associated with the digital innovation unless Duke OTC determines that the development of the digital innovation was outside of your scope of employment at Duke University or did not use Duke funds/substantial resources.

For this, you will need to complete and submit to Duke OTC an invention disclosure form (IDF).  The IDF will be reviewed by Duke OTC to ascertain the facts surrounding the development of the digital innovation.

If you are working with an outside vendor who is not acting as an independent contractor providing consulting services (IT development) for a fee, then please contact an OTC DI Team Member

An example of such an outside vendor is an IT company wanting to collaborate with you in developing or piloting a product prototype that they have interest in commercializing. Duke OTC may be able to assist you in protecting your IP interests as a Duke inventor/developer and explore joint IP ownership scenarios with such a vendor.

If you are working with an independent contractor (for example a software development consultant) using grant monies or internal funds administered by Duke University, it is critical to work through Duke Procurement and use a “work for hire” contract to engage the vendor services.

Under the “work for hire” contract, the intellectual property rights associated with the Digital Innovation will be owned by Duke University. In the absence of a written “work for hire” contract, it is possible that the vendor may assert ownership rights to the digital innovation which can create immense complications.

If you would like to work with another university/non-profit or private company to develop a digital innovation and you are using grant monies or internal funds than it is critical to work through Office of Research Administration (if you are employee of Duke University) or Office of Research Support (if you are employee of Duke Health).

It is advised to use a research contract or sub-contract or collaborative research agreement to collaborate with another university or private company.

The research contract or sub-contract will have terms for joint ownership of IP created under collaborations. Duke OTC can assist in negotiating and executing an Inter-Institutional Agreement (IIA) for management of joint IP with another university. There is also the option to work through Duke Procurement under a “work for hire” agreement where Duke will own the IP associated with the digital innovation developed under the agreement.

Considerations for Development of DI Health Innovations

Download Digital Innovation Roadmap

  1. Is there any Duke or individual MD/staff ownership?
  2. If any conflict, identify if management plan has been executed.
  3. Is there data sensitivity (PHI, credit cards, intellectual property, student information, social security numbers, etc.)?

RESEARCH INTEGRITY OFFICE (RIO)

  1. Approved Research protocol vs. quality/operational?
  • If state research, review if exempt or retrospective review
  • If quality/operational, identify DIHI grant or DUHS Administrator who sponsors project?
  1. What is the origin/source of data?
  2. What data elements will be sourced?
  3. Evaluate if de-identified or LDS is sufficient
  4. Is the plan to move any PHI outside DUHS?
  1. Is all sensitive data encrypted in transit?
  2. Is the release of data to all external parties authorized and approved by the Institutional Review Board (IRB)?
  3. Is Duke involved in the created of (or paying a vendor to create) web or mobile technology?
  4. Does the company need access to the Duke network?

Commercialization

The primary process of commercializing Digital Innovation has always been licensing. Licensing of Digital Innovation has primarily been based on copyrights and contract law, but could also include other forms of IP including patent rights, trademarks, data rights etc. Sometimes licensing of Digital Innovation is based on a combination of IP rights and contract law terms.

Duke OTC supports licensing of Digital Innovation based on software, databases, and creative works. These licenses could be exclusive proprietary licenses (for example a software startup spinning out of Duke) or non-exclusive proprietary licenses (when licensing to more than one entity) or academic research licenses (when licensing to other academic institutions) or open source/open data licenses (for open licensing) or evaluation licenses (for evaluation purposes only) or end-user licenses (when licensing to end users).

A software license is a legal instrument (usually by way of contract law, with or without printed material) governing the use or redistribution of software under copyrights and contract law. Under United States copyright law, almost all software is copyright protected, in source code as also object code form. A typical software license grants the licensee permission to use or sometimes modify the software in ways where such a use or modification would otherwise potentially constitute copyright infringement of the software owner’s rights under copyright law. An open source license is also essentially a software license.

A database license is also similarly based on copyrights on the database compilation along with contract law to protect the underlying data. If the software has associated patent rights or trademarks, the software license may include these IP rights also.

A pure data license without associated copyrights on a database compilation could be based on contract law only.

A creative works license is similar to software and database license and based on copyrights and contract law.

The right to create derivative works is one of the exclusive rights of a copyright holder. This modification or adaptation right is often considered one of the most powerful of all the exclusive rights in copyright, because the right to adapt and modify permits the grantee the right to improve or add to a copyrighted work and creates new copyrights that could vest in the developer of the derivative work, subject to the copyright holder’s original rights in the preexisting work.

Disseminating DI for Research

Data sharing policies related to research projects funded by federal agencies require investigators to share with other academic researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work. Data, in this case, means recorded information, regardless of the form or media on which it may be recorded, and includes:

  • Writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations,procedural manuals,forms, diagrams, workflow charts, equipment descriptions, data files, data processing or computer programs(software), statistical records, and other research data.

This data sharing obligation is within the academic scientific community and does not extend to commercial researchers in private industry.

Dissemination or sharing of digital innovation funded under federal research dollars including software, databases/data, creative works and associated documentation to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. This sharing needs to be at no more than incremental cost and within a reasonable time.

Given that digital innovations like software code, databases and creative works funded by federal research can be shared with other researchers electronically, the incremental cost is generally minimal and the dissemination is quick.

Public Domain (dedication to the public domain) or Open Licensing (open source for software, open data for databases/data or creative commons for creative works) are two of the mechanisms available for dissemination of scientific results. There are other mechanisms available for dissemination

The mechanisms available to disseminate scientific results associated with Digital Innovations to the research community include:

  • Evaluation Licenses/Shareware
  • Academic Research Licenses
  • Open Licenses (Open Source/Open Data/Creative Commons)
  • Public Domain Dedication/Freeware

 

Public domain deduction or Freeware could adversely impact the technology translation and commercialization potential of digital innovations. It also provides little to no attribution to the developers/authors.

Open Licenses, like open source, in turn, could limit the translation and commercialization potential of digital innovations.

The other mechanisms that generally do not impact the translation or commercialization potential of digital innovations include evaluation licenses (generally used with non-academic entities) and academic research licenses (used with academic entities).

Please contact Duke OTC if you would like to use evaluation licenses or academic research licenses for dissemination. We have template agreements that we can use to help you in the dissemination process. We are also a proponent of responsible open licensing. If you would like to use the public domain or open licensing please be aware that some amount of diligence is generally required.

 

Open Source and Open Data

Open-source software is a type of computer software whose source code is released under an open source license in which the copyright holder grants users the rights to study, change, and distribute the software to anyone and for any purpose. Open source licenses are software licenses that comply with the Open Source Definition — in brief, they allow software to be freely used, modified, and shared. The Open Source Initiative’s (OSI) definition of open source is recognized by governments internationally as the standard or de facto definition.

The freedom to use the open sourced software program for any purpose, including commercial, is part of the Open Source Definition. Open source licenses do not discriminate against fields of endeavor whether commercial or academic. As such, we cannot use an approved open source license and then put additional restrictions restricting it for academic use.

There are two main types of open source licenses: copyleft licenses and permissive licenses.

Copyleft refers to open source licenses that allow users to create derivative works but require the users to use the same license as the original work to distribute the new work including the derivatives.

For example, if you develop some source code and release it under a copyleft license, and then someone else modifies that software and distributes their modified version, then this modified version must also be licensed under the same copyleft license (or an upward compatible copyleft license) — including any new code written specifically to go into the modified version. Both the original and the new work are effectively open source; the copyleft license is “viral” or “sharealike” in nature and simply ensures that requirement to open source is perpetuated to all downstream derivatives.

Most copyleft licenses are open source, but not all open source licenses are copyleft. When an open source license is not copyleft, that means software released under that license can be used as part of programs distributed under other licenses, including proprietary (non-open source) licenses. Such licenses are usually called either non-copyleft or permissive licenses.

A permissive license is simply a non-copyleft open source license — one that guarantees the freedoms to use, modify, and redistribute, but that permits proprietary derivative works which do not need to be open sourced.

If the digital innovators feel that the software they developed has commercial potential now or could be commercialized in the future, innovators are advised to submit an invention disclosure on the software and consult with Duke OTC prior to open sourcing the software.

Dissemination or sharing of digital innovation funded under federal research dollars including software, to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. Open source licensing is one of the mechanisms available to meet these obligations and Duke OTC can help select an open source license or other mechanisms like academic research licenses to meet our data sharing obligations.

If digital innovators feel that the software they developed has or could have commercial potential, they are advised to submit an invention disclosure on the software and consult with Duke OTC for advice on open sourcing the software.

For Duke owned software innovations (i.e. software not containing any third-party code or dependencies) with limited commercial potential or research software tools, Duke OTC generally recommends the use of copyleft or permissive licenses which do not have patent license grant clauses. The copyleft licenses that Duke OTC supports for use with source code owned by Duke University are:

Duke OTC does not recommend the use of copyleft licenses that contain implicit patent license grants like the later versions of GNU General Public Licenses like GNU General Public License, Version 3 (GPL 3.0) or GNU Library General Public License, Version 3.1 (LGPL 3.1). However, if innovators need to use these license, Duke OTC could consider requests to release copyright ownership to the innovators so that they can use these open source licenses under their personal copyrights. Please contact Duke OTC for further details.

The popular permissive licenses that Duke OTC recommends are:

Due to patent grant language in the Apache License 2.0, Duke OTC supports the use of Apache License 2.0 on a case by case basis. Please contact Duke OTC for further details.

Open Source Software can be commercialized and monetized. One can sell services based on the code (i.e., sell your time), sell warranties and other assurances, sell customization and maintenance work, license the trademark, etc. 

Please contact Duke OTC if you would like to explore commercialization of Duke owned open source software.

Open data is the idea that some data should be freely available to everyone to use and republish as they wish, without restrictions from copyright, patents or other mechanisms of control. The goals of the open data movement are similar to the open source movement with software.

If the digital innovators feel that the database/data they developed has commercial potential now or could be commercialized in the future, innovators are advised to submit an invention disclosure on the software and consult with Duke OTC prior to open licensing the database/data.

Dissemination or sharing of digital innovation funded under federal research dollars including databases/data, to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. Open data licensing is one of the mechanisms available to meet these obligations and Duke OTC can help select an open data license or other mechanisms like academic data use or data sharing agreements to meet our data sharing obligations.

In selecting an open data license, diligence is required including determining ownership of data, use of third-party data etc.

If your database contains Patient Health Information (PHI), please contact IRB at the University or Compliance at the Health System for meeting data protection obligations including HIPAA.

For Duke owned databases (i.e. databases not containing any third-party data or linked data) with limited commercial potential or research databases, Duke OTC generally recommends the use of Creative Commons licenses.

Creative Commons licenses should not be used with software but can be used with databases since a database is copyrightable (with regards to the compilation). If digital innovators would like to disseminate data to the scientific community but retain commercialization options for the future, they would be advised to use a non-commercial version of the creative commons licenses like CC-BY-NC-SA 4.0 which would also require creators of derivative works to use the same license. They could further restrict derivative rights completely by using CC-BY-NC-ND 4.0.

Open data commons licenses like Open Data Commons Open Database License (ODbL) and Open Data Commons Attribution License can also be used to disseminate data which require attribution.

However, please note that these licenses give full commercialization rights to the users. Please contact Duke OTC is you would like to dedicate the database/data to the public domain or use public domain licenses like CCO or PDDL.

Please also note that dedication to public domain or use of public domain licenses may not provide attribution.

Creative Works

Creative works can be protected under copyrights. Creative works other than digital innovations like software, screen materials, websites and databases that can be copyrighted include:

  • literary works including manuals, books, etc.
  • scientific and technical papers
  • online writing, such as a blog or series of articles
  • musical works and sound recordings, including lyrics
  • movies and other audiovisual works
  • pictorial works (includes maps and architectural plans), graphics, sculpture
  • pantomimes and choreographic works (if they have been recorded)

Publication is not necessary for copyrighting a creative work, but your creative work must somehow be preserved in some form or be able to be reproduced, to be copyrighted.

Creative works that are not fixed in some tangible form of expression cannot be copyrighted. These include:

  • Ideas, procedures, methods, systems, processes, concepts, principles, discoveries, or devises, as distinguished from a description, explanation, or illustration.
  • Titles, names, short phrases, and slogans. (You may be able to trademark or service mark these.)
  • A speech or lecture that isn’t recorded or written out.
  • Familiar symbols or designs, mere variations of typographic ornamentation, lettering or coloring
  • Mere listings of ingredients or contents (but a recipe with instructions can be copyrighted)
  • “Common Property” works that have no original authorship, for example, standard calendars, tape measures and rules, height/weight charts, lists or tables taken from public documents or other common sources.
  • Works that are in the public domain, for which the copyright has expired.

As regards copyrights and other intellectual property rights (excluding patent rights), notwithstanding the general principles respecting individual ownership expressed in Duke’s copyright policy, ownership of such intellectual property rights arising in certain categories of academic works  including creative works (i.e., works primarily related to the teaching or research missions of the university) listed below shall vest (as works for hire or the equivalent) in Duke:

  • Works supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke.
  • Works supported by grants, extraordinary allowance or subventions (whether in money or money’s worth, and whether or not supported by outside sources under contract), when designated as such in advance by the University.
  • Databases and similar collections of information which are obtained primarily on behalf of schools or departments rather than individuals, or which involve issues of privacy (as in the case of medical patients or identifiable human subjects) or require approval by the University’s Institutional Review Board.
  • Computer programs, when the programs are primarily created to perform utilitarian tasks.
  • Works by persons working as members of the Duke community, when numerous individual original contributions are indistinctly merged, as a practical matter, into a new and distinct work fixed in a tangible medium of embodiment, and the individual creators have not entered into an agreement with respect to joint authorship.

Works are under copyright protection the moment they are created and fixed in a tangible form that it is perceptible either directly or with the aid of a machine or device. In general, registration is voluntary and relatively inexpensive. Copyright exists from the moment the work is created. You will have to register, however, if you wish to bring a lawsuit for infringement of a U.S. work. Registered works may be eligible for statutory damages and attorney’s fees in successful litigation.

In copyright law, a copyright notice is a notice of statutorily prescribed form that informs users of the underlying claim to copyright ownership in a published work. When a creative work is developed to be published, shared or licensed under the authority of the copyright owner, a notice of copyright may be placed on the work. The use of the notice is the responsibility of the copyright owner and does not require permission from, or registration with, the U.S. Copyright Office.

Use of the notice informs the public that a creative work is protected by copyright, identifies the copyright owner, and shows the year of first. Generally, the copyright notice should be placed in such a way that it gives reasonable notice of the claim of copyright. The notice should be permanently legible to an ordinary user of the work under normal conditions of use and should not be concealed from view upon reasonable examination.

For example, Copyright notices for Duke owned creative works can be added as given below:

Copyright 2018. Duke University. All Rights Reserved.

Copyright 2015 – 2018. Duke University. All Rights Reserved.

Open Source Software can be commercialized and monetized. One can sell services based on the code (i.e., sell your time), sell warranties and other assurances, sell customization and maintenance work, license the trademark, etc. 

Please contact Duke OTC if you would like to explore commercialization of Duke owned open source software.

Creative Commons licenses can be used to disseminate creative works openly. If authors would like to disseminate a creative work but retain commercialization options for the future and restrict users rights to create derivatives, they would be advised to use a non-commercial version of the creative commons licenses like CC-BY-NC-ND 4.0.

Yes. If the creative work is owned by Duke University, Duke OTC can assist with commercialization efforts. Even if you used a Creative Commons license to disseminate your creative work, as long as you used a non-commercial version of the creative commons license, commercial licenses can still be used to monetize the work.

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