Chapter 9. Research Data and Intellectual Property
Thomas D. Mays and Francis L. Macrina
Charmasson H, Buchaca J. 2008. Patents, Copyrights & Trademarks for Dummies, 2nd ed. Wiley Publishing, Inc, Hoboken, NJ.
Council on Governmental Relations. 2012. Access to and Retention of Research Data: Rights and Responsibilities. Council on Governmental Relations, Washington, DC. http://www.cogr.edu/Pubs_ResearchAdmin.cfm.
Kanare HM. 1985. Writing the Laboratory Notebook. American Chemical Society, Washington, DC.
Miller AR, Davis MH. 2012. Intellectual Property, Patents, Trademarks, and Copyright in a Nutshell, 5th ed. West Academic Publishing, St. Paul, MN.
National Research Council. 2003. Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences. National Academies Press, Washington, DC. http://www.nap.edu/catalog.php?record_id=10613.
National Research Council. 2004. A Patent System for the 21st Century. National Academies Press, Washington, DC. http://www.nap.edu/catalog.php?record_id=10976.
The website of the U.S. Copyright Office contains much general information about copyrights as well as a search engine for finding copyright registrations:
Data Sharing Regulations/Policy/Guidance Chart for NIH (National Institutes of Health) Awards:
The NIH’s Frequently Asked Questions about Data Sharing Web page includes the definition of “final research data” and other important contextual information on research data and data sharing:
The NIH Data Sharing Policy and Implementation Guidance Web page includes sample data sharing plans:
NIH Grants Policy Statement, which contains the data sharing policy (Section 220.127.116.11):
NIH Data Sharing Policy brochure:
NIH Policy on the Sharing of Model Organisms for Biomedical Research brochure:
National Science Foundation’s (NSF) Dissemination and Sharing of Research Results Web page:
NSF information on data management plans for grant applications to the Directorate for Biological Sciences:
Federal Trade Commission resources
The 2004 report To Promote Innovation: the Proper Balance of Competition and Patent Law and Policy can be accessed at
The 2011 report The Evolving IP Marketplace: Aligning Patent Notice and Remedies with Competition can be accessed at
Freedom of information
The National Freedom of Information Coalition website is maintained by “a nonpartisan alliance of citizen-driven nonprofit freedom of information organizations, academic and First Amendment centers, journalistic societies and attorneys.” This site contains current information on Freedom of Information Act issues.
Genetic technology and intellectual property
National Human Genome Research Institute’s Intellectual Property and Genomics Web page:
A 2013 article discussing the Supreme Court’s review of Myriad Genetics’ gene patents can be found at:
For an analysis of the decision on SCOTUSblog, see:
Intellectual property: general information
AIPLA (American Intellectual Property Law Association) is a bar association of attorneys in private and corporate practice and government service and offers a number of useful documents, specifically How To Protect and Benefit From Your Ideas:
Information on patents and other forms of intellectual property can be found at the website of the U.S. Patent and Trademark Office (PTO):
Patent resources may be found at the site offered by the law firm of Oppedahl and Larson:
Access to the U.S. PTO site is free and permits searching and downloading of full-text (or image) copies of U.S. patents and published applications:
A search engine for trademarks can be found on the U.S. PTO home page under “Trademarks”:
Civil misappropriation - Taking and using the property of another without permission for the sole purpose of capitalizing unfairly on the goodwill and reputation of the property owner.
Common law - Generally refers to principles of law developed through litigation in the courts, rather than statutes enacted through the legislative process.
Contract law - Subset body of law developed as common law and statute that relates to agreements between parties, including rights and obligations of parties.
Copyright - A property right over intangible intellectual property concerning original works of authorship fixed in any tangible medium of expression.
Derivative work - Work that is compiled by the author from preexisting works; a copyright to a derivative work extends only to that material contributed by the author and not to the preexisting work.
Fair use - Statutory protected form of noncommercial use of work under copyright that includes use of work for purposes of criticism, comment, news reporting, teaching, scholarship, and research.
Freedom of Information Act - Statute requiring U.S. government agencies to provide upon request documents in the possession of the agency and those whose research is supported under a federal funding agreement and all research data produced therefrom, not otherwise exempted from release under statute (5 U.S.C. §551 et seq. [1977 and Supp. 2002]). There are nine categories of exemptions that are intended to protect the release of sensitive information.
Grantee - Institution, organization, individual, or other person designated in the grant; the legal entity to whom a grant is awarded. In the context of federal funding, the party receiving a grant of financial assistance, as provided under 45 CFR Part 74, for grants from the U.S. Public Health Service.
Patent—Design - Design patents provide a 14-year period of protection for the ornamental features of an article of manufacture.
Patent—Plant - Plant patents provide the same term as discussed below for utility patents. Plant patents provide protection for those plants (and parts thereof) that the inventor discovers and is able to reproduce asexually, other than tubers (e.g., potatoes).
Patent—Utility - For those patent applications filed on or after June 8, 1995, the term begins on the date the patent issues and continues for 20 years from the filing date of the earliest filed application (e.g., the term of a patent issuing on January 11, 1996, from an application filed July 11, 1995, expires on July 11, 2015; note this is an enforceable term of 19 1/2 years). Utility patents provide protection for those inventions that are useful, novel, and nonobvious and that constitute a process, machine, manufacture, or composition of matter, or any new improvement thereof; this includes the invention claimed as a drug or claimed as a use of a drug.
Principal investigator - A single individual, designated by the grantee in the grant application and approved by the Secretary of the U.S. Department of Health and Human Services, who is responsible for the scientific and technical direction of the project.
Provisional patent application - An informal patent application filed with the PTO that is less expensive to prepare than a regular utility application. The provisional patent application is not considered by the PTO but remains on file for 1 year. Once filed, this document precludes a subsequent public disclosure of the application’s subject matter from destroying the patentable novelty of the invention. Disclosure without provisional patent application protection might otherwise result in forfeiture of patent rights. A regular patent application must be filed by the end of the 1-year period of the provisional patent application, or the opportunity to patent the invention will be lost.
Statute - An act of the legislature declaring, commanding, or prohibiting something; a law.
Trade secret - A formula, pattern, device, or compilation of information that is used in one’s business and that gives one opportunity to obtain advantage over competitors who do not know or use it.
Trademark - A distinctive mark that indicates the source of a particular product or service.