AMA Manual of Style - Stacy L. Christiansen, Cheryl Iverson 2020

Intellectual Property: Ownership, Access, Rights, and Management
Ethical and Legal Considerations

[Will copyright survive the new technologies?] That question is about as bootless as asking whether politics will survive democracy. The real question is what steps it will take to ensure that the promised new era of information and entertainment survives copyright. History offers a clue.

Paul Goldstein¹

Intellectual property is a legal term for that which results from the creative efforts of the mind (intellectual) and that which can be owned, possessed, and subject to competing claims (property).² Three legal doctrines governing intellectual property are relevant for authors, editors, and publishers in biomedical publishing: copyright (the law protecting authorship and publication), patent (the law protecting invention and technology), and trademark (the law protecting words and symbols used to identify goods and services in the marketplace).¹ This section focuses primarily on intellectual property and copyright law as they relate to ownership, access, rights, and management of content and publication.

5.6.1 Ownership and Control of Data.

Conceptual application of the term property to scientific knowledge is not new, but advances in science and technology, economic factors, regulations, and policies have fueled disputes, concerns, and changes in attitude about data ownership, control, transparency, and access.^{1,2,3,4,5,6,7,8,9,10,11} Data used in biomedical research are increasingly complex and include large data sets, models, algorithms, and metadata (data that provide information or characteristics about other data). With the exception of commercially owned information, scientific data are generally viewed as a public good, allowing others to benefit from knowledge of and access to the information without decreasing the benefit received by the individual who originally developed the data. However, personal, professional, financial, and proprietary interests can interfere with the altruistic goals of data sharing.^{7,8,9,12,13,14,15}

5.6.1.1 Data: Definition and Types of Ownership.

For purposes herein, data include but are not limited to written and digital laboratory notes, documents, research and project records, experimental materials (eg, reagents, cultures), descriptions of collections of biological specimens (eg, cells, tissue, genetic material), descriptions of methods and processes, patient or research participant records and measurements, results of bibliometric and other database searches, illustrative material and graphics, audio and video recordings, analyses, surveys, questionnaires, responses, data sets (eg, protein or DNA sequences, microassay or molecular structure data), databases, metadata (data that describe or characterize other data), and algorithms. The US National Institutes of Health (NIH) defines digital scientific data as “the digital recorded factual material commonly accepted in the scientific community as necessary to validate research findings including data sets used to support scholarly publications, but does not include laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens . . . The definition of digital scientific data includes data that are used to support a scientific publication as well as data from completed studies that might never be published. It may include data that support or refute a hypothesis, but does not include draft or preliminary data sets.”⁶ The NIH definition does not include software.

In scientific research, 3 common arenas exist for ownership of data: the government, the commercial sector, and academic or private institutions or foundations. Although perhaps a less frequent occurrence, when data are produced by a researcher or other individual without a relationship to a government agency, a commercial entity, or a private institution, the data are owned by that individual.

Any information produced by an office or employee of the US federal government during his or her employment is owned by the government.¹⁶ The US Freedom of Information Act (FOIA), enacted in 1966, is intended to ensure public access to government-owned information (except trade secrets, financial data, national defense information, and personnel or medical records protected under the Privacy Act).^2,17 Access to documents with such data that are otherwise unavailable may be obtained through a FOIA request in the United States. Many countries have implemented similar freedom of information legislation.

Data produced by employees in the commercial sector (eg, a pharmaceutical, device, or biotechnology company, health insurance company, or for-profit hospital or managed care organization) are typically governed by the legal relationship between the employee and the commercial employer, granting all rights of data ownership and control to the employer. However, if the data have been used to secure or are funded by a government grant or contract, such data may be obtained by an outside party through a FOIA request or by a court-ordered subpoena.^3,17

The US Bayh-Dole Act of 1980 permits universities or nonprofit institutions to have control of the intellectual property generated from federally funded research. For example, according to guidelines established by Harvard University and subsequently adopted by other US academic institutions (as well as those in other countries), data developed by employees of academic institutions are owned by the institutions.^18,19 These policies allow access to data by university scientists and allow departing scientists to take copies of data with them, but the original data remain at the institution. However, researchers do not always understand university intellectual property policies or data management plans, or who owns data, how to interpret and comply with funder mandates for data access, how long data should be retained, data depositing requirements, costs associated with data management and depositing, and a host of ethical issues related to data management, access, and sharing.^18,20

5.6.1.2 Data Transparency, Sharing, and Length of Storage.

The notion that data should be transparent and shared with others for review, criticism, and replication is a fundamental but perhaps idealistic tenet of the scientific enterprise. Sharing research data encourages scientific inquiry, permits reanalysis, promotes new research, facilitates education and training of new researchers, permits creation of new data sets when data from multiples sources are combined, and helps maintain the integrity of the scientific record.^2,4,5,6,10 However, the practice of data sharing has varied widely, and it was not until the early 2000s that guidelines for data sharing were developed^4,5 and only recently that more assertive calls for data transparency have been promulgated for medical research.^{6,8,10,21,22,23}

Although data sharing is essential for research, costs and risks may result in restrictions on access to certain data imposed by the owner, initial investigator, or sponsor or funder. Potential costs and risks to the owner or initial investigator include technical and financial obstacles for data storage, reproduction, and transmission; loss of academic or financial reward or commercial profit; unwarranted or unwanted criticism; risk of future discovery or exploitation by a competitor; the discovery of error or fraud; and breaches of confidentiality and violations of rights to privacy of personal data. The discovery of error or fraud and breaches of confidentiality have important relevance in scientific publishing. Discovery of error or fraud, if corrected or retracted in the literature, is clearly beneficial. For research involving humans, epidemiologic and statistical procedures are available to maintain confidentiality for individual study participants, but challenges to protect identifying data of individual research participants remain^6,10,22 (see 5.4, Scientific Misconduct; 5.8, Protecting Research Participants’ and Patients’ Rights in Scientific Publication; and 5.11.10, Corrections [Errata]).

A number of research sponsors and governmental agencies have developed policies to encourage data transparency and sharing.^{5,6,22,23,24,25} For example, in 2003, the NIH began requiring investigators to include a plan for data sharing in all grant applications that request $500  000 or more in direct costs.⁵ That same year, the Wellcome Trust began encouraging its funded investigators to release data to the public from large-scale biological research projects, such as the International Human Genome Sequencing Consortium. The Wellcome Trust has required funded researchers to maximize the value of research with data management plans for research that “is likely to create significant research outputs that are of value to other researchers and users,” such as clinical trials, longitudinal studies of patient and population cohorts, genetic studies, large-scale neuroimaging studies, computational models and simulations of neurologic, physiologic, or other biological systems, and the creation and development of databases.²⁴

The 2003 NIH policy on data sharing, which is still in force, states that “data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.”⁵ In 2013, the US Office of Science and Technology Policy released a policy titled “Increasing Access to the Results of Federally Funded Scientific Research,” which directs “peer-reviewed publications and digital scientific data resulting from federally-funded scientific research to be publically accessible.”²⁶

Focusing on clinical trials, the US Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), issued a report in 2015 on data sharing that concludes with the following: “Responsible sharing of clinical trial data will allow other investigators to carry out additional analyses and reproduce published findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators.”¹⁰ The IOM/NAM report also acknowledged risks, burdens, and challenges to the sharing of clinical trial data, including “the need to (1) protect the privacy and honor the consent of clinical trial participants; (2) safeguard the legitimate economic interests of sponsors (eg, intellectual property and commercially confidential information); (3) guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health; (4) give researchers who put effort and time into planning, organizing, and running clinical trials adequate time to analyze the data they have collected and appropriate recognition for their intellectual contributions; and (5) assuage the fear of research institutions that requirements for sharing clinical trial data will be unfunded mandates.”¹⁰ In addition, any policies promoting data sharing should acknowledge the financial costs associated with a priori planning of research to address the above needs and the costs associated with data deposit and maintenance. The IOM/NAM report has specific recommendations for various stakeholders, including funders and sponsors, disease advocacy organizations, regulatory and research oversight bodies, institutional review boards and research ethics committees, investigators, research institutions and universities, membership and professional societies, and journals.

Several proposals prescribe the minimum optimal time to keep data (eg, 2-7 years). However, there is no universally accepted standard for data retention by academic and research institutions. For example, the NIH requires its funded scientists to keep data for a minimum of 3 years after the closeout of a grant or contract agreement and recognizes that an investigator’s academic institution may have additional policies regarding the required retention period for data.⁵ The NIH also gives the right of data management, including the decision to publish, to the principal investigator.⁵ The European Medicines Agency recommends that essential documents for clinical trials be retained for at least 15 years after completion or discontinuation of the trial.²⁵ With new policies for data transparency and recommendations for deposit in accessible repositories, data may be available for longer periods in both public and private repositories. However, length of data storage and retention in such repositories is one of the many challenges to an effective data management policy and culture (see 5.6.1.5, Record Retention Policies for Journals).

5.6.1.3 Data Sharing, Deposit, and Access Requirements of Journals.

In 1985, the US Committee on National Statistics, which is part of the National Research Council (NRC),²⁷ released a report on data sharing that continues to serve as a useful guide for researchers, authors, editors, and journals. Among the committee’s recommendations, the following have specific relevance for scientific journal publication²⁷:

Data sharing should be a regular practice.

Initial investigators should share their data by the time of the publication of initial major results of analyses of the data except in compelling circumstances, and they should share data relevant to public policy quickly and as widely as possible.

Investigators should keep data available for a reasonable period after publication of results from analyses of the data.

Subsequent analysts who request data from others should bear the associated incremental costs and they should endeavor to keep the burdens of data sharing to a minimum. They should explicitly acknowledge the contribution of the initial investigators in all subsequent publications.

Journal editors should require authors to provide access to data during the peer review process.

Journals should give more emphasis to reports of secondary analyses and to replications.

Journals should require full credit and appropriate citations to original data collections in reports based on secondary analyses.

Journals should strongly encourage authors to make detailed data accessible to other researchers (although some may view this as outside the purview of a journal’s responsibilities).

Similar to policies on data sharing and storage for academic and research institutions, policies for scientific journals are highly variable and not always available. In 2002, an NRC review of 56 of the most frequently cited life science and medical journals reported that 39% had policies on data sharing and 45% had no stated policy.⁴ Of the 18 medical journals in this review, only 22% had policies on data sharing. In a 2009-2010 survey of 1329 scientists in a variety of disciplines, 75% reported that they share their data with others, but only 36% reported that others can easily access those data.⁸ At that time, only 55% of scientists reported that their funders required that they provide a data management plan. That survey revealed multiple perceived and actual barriers to data sharing by scientists, including lack of established standards for metadata associated with the data as well as data formatting, archiving, and depositing in repositories. In 2013-2014, a follow-up survey was conducted among 1015 of the scientists who had participated in the previous survey and after many funders had begun to implement policies that required data sharing and data management plans.⁹ The follow-up survey found that scientists were more willing to share data, but perceived risks and barriers continue to challenge actual data sharing practices.

To address the lack of standard policies for data sharing among scientific journals, in 2003 the NRC recommended the following⁴:

Scientific journals should clearly and prominently state (in their instructions for authors and on their websites) their policies for distribution of publication-related materials, data, and other information.

Policies for sharing materials should include requirements for depositing materials in an appropriate repository.

Policies for data sharing should include requirements for deposition of complex data sets in appropriate databases and for the sharing of software and algorithms integral to the finding being reported.

The policies should also clearly state the consequences for authors who do not adhere to the policies and the procedure for registering complaints about noncompliance.

The NRC also proposed a set of principles that may be useful to journals developing policies on data sharing⁴:

Authors should include in their publications data, algorithms, or other information that is central or integral to the publication—that is, whatever is necessary to support the major claims of the paper and would enable one skilled in the art to verify or replicate the claims.

If central or integral information cannot be included in the publication for practical reasons (for example, because a data set is too large), it should be made freely (without restriction of its use for research purposes and at no cost) and readily accessible through other means (for example, online). Moreover, when necessary to enable further research, integral information should be made available in a form that enables it to be manipulated, analyzed, and combined with other scientific data.

If publicly accessible repositories for data have been agreed on by a community of researchers and are in general use, the relevant data should be deposited in one of these repositories by the time of publication.

Authors of scientific publications should anticipate which materials integral to their publications are likely to be requested and should state in the “Materials and Methods” section or elsewhere how to obtain them.

If material integral to a publication is patented, the provider of the material should make the material available under a license for research use.

Focusing specifically on clinical trials, the 2015 IOM/NAM report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk,¹⁰ recommends that journals do the following:

Require authors of both primary and secondary analyses of clinical trial data to document that they have submitted a data sharing plan at a site that shares data with and meets the data requirements of the World Health Organization’s International Clinical Trials Registry Platform before enrolling participants, and

Commit to releasing the analytic data set underlying published analyses, tables, figures, and results no later than the times specified in this report (eg, the full analyzable data set with metadata no later than 18 months after study completion—with specified exceptions for trials intended to support a regulatory application—and the analytic data set supporting publication results no later than 6 months after publication); and

Require that submitted manuscripts using existing data sets from clinical trials, in whole or in part, cite these data appropriately; and

Require that any published secondary analyses provide the data and metadata at the same level as in the original publication.

While funders and governmental agencies continue to sort out practical and effective policies of data sharing, storage, and access, many journals currently encourage data sharing by the authors of articles they publish, and some journals require data sharing as a condition of publication. In 2017, the International Committee of Medical Journal Editors (ICMJE) issued a statement on sharing clinical trial data that supports the recommendations of the IOM/NAM and that indicates new requirements for sharing of deidentified individual patient data underlying the results presented in published articles.²² For reports of randomized clinical trials, ICMJE requires authors to provide a data sharing statement that indicates if data, including individual patient data, a data dictionary that defines each field in the data set, and supporting documentation, will be made available to others; when, where, and how the data will be available; types of analyses that are permitted; and if there will be any restrictions on the use of the data. Data sharing statements may also be submitted for reports of other types of studies, but the ICMJE member journals only require this for reports of clinical trials.

Data sharing statements should address the following items:

Data

Will the data collected for your study, including individual patient data and a data dictionary defining each field in the data set, be made available to others?

Yes or no. (If no, authors may explain why data are not available.)

List all data that will be made available:

Deidentified participant data

Participant data with identifiers

Data dictionary

Other (please specify)

List where to access these data. Provide complete URL if data will be available in a repository or website, or provide complete email address if request for data must be sent to an individual.

List the beginning date and end date (if applicable) when these data will be available. If the beginning date of data availability will be when the article is published, please indicate “with publication.”

With publication

At a date different from publication

Beginning date

End date (if applicable)

Supporting Documents

If your manuscript is accepted for publication, the journal will publish your trial protocol, including the statistical analysis plan, and any amendments as online supplements. Please list any other supporting documents that you wish to make available (eg, statistical/analytic code, informed consent form).

Statistical/analytic code

Informed consent form

None

Other (please specify)

List where to access these documents. Provide complete URL if the documents will be available in a repository or website, or provide complete email address if request for documents must be sent to an individual.

List the beginning date and end date (if applicable) when these data will be available. If the beginning date of data availability will be when the article is published, please indicate “with publication.”

With publication

At a date different from publication

Beginning date

End date (if applicable)

Additional Information

Indicate the types of analyses for which the data will be made available (eg, for any purpose or for a specified purpose).

Indicate the mechanism by which the data will be made available (eg, with investigator support, without investigator support, after approval of a proposal, or with a signed data access agreement).

List any additional restrictions on the use of the data or any additional information.

If you would like to offer context for your decision not to make the data available, please enter it below (optional).

Examples of data sharing statements are shown in 2.10.15, Data Sharing Statement.

A number of journals have had data sharing or availability polices that range from encouragement to strict requirements for different types of data for more than a decade, including Nature, Science, the Public Library of Science (PLOS) journals, and a number of medical journals, but policies have not been fully standardized. For example, in 2007 the Annals of Internal Medicine began encouraging data transparency by publishing a statement with research articles that indicates authors’ willingness to share the study protocol (original and amendments), statistical code used to generate results, and the data set from which the results were derived.²⁸ Since that time, the journal has encouraged sharing but has not required it and notes that “access to these items may range from completely unrestricted (eg, free availability of all the items via posting on an open-access website) to restricted (eg, availability of certain portions of the items to approved individuals through written agreements with the author or research sponsor).”²⁹ The BMJ has a similar policy, and authors of original research articles are required to include a data sharing statement when submitting their article. The statement should explain what additional unpublished data from the study—if any—are available, who can access the data, and how the data can be obtained.³⁰ BMJ Open also lists examples of repositories that accept data deposits and provide permanent links to the deposits and has a useful list of resources for data management and sharing.³¹ As members of the ICMJE, both journals require authors of clinical trials to include data sharing statements.

For many years, a number of scientific journals (eg, Science,³² Nature³³) have required authors to submit large data sets (eg, protein or DNA sequences, microarray or molecular structure data) to approved, accessible databases and to provide accession numbers as a condition of publication. It is appropriate for authors and journals to include links to public repositories for such data in the Methods or Acknowledgment sections of articles (see 2.10.18, Manuscript Preparation for Submission and Publication, Acknowledgments [Article Information], Additional Information [Miscellaneous Acknowledgments]).

However, both Science and Nature now indicate in their instructions for authors that they require authors to make materials, study protocols, and data codes necessary for study replication available to others without qualification or restriction—unless formally explained to the editors at the time a manuscript is submitted.^32,33 Science states the following in its information for authors³²:

Data and Materials Availability After Publication

After publication, all data and materials necessary to understand, assess, and extend the conclusions of the manuscript must be available to any reader of a Science Journal. After publication, all reasonable requests for data, code, or materials must be fulfilled. Any restrictions on the availability of data, code, or materials, including fees and restrictions on original data obtained from other sources must be disclosed to the editors as must any Material Transfer Agreements (MTAs) pertaining to data or materials used or produced in this research, that place constraints on providing these data, code, or materials. Patents (whether applications or awards to the authors or home institutions) related to the work should also be declared.

Unreasonable restrictions on data, code, or material availability may preclude publication. Problems in obtaining access to published data are taken seriously by the Science Journals and can be reported at science_data@aaas.org.

Nature has a similar policy and adds, “After publication, readers who encounter refusal by the authors to comply with these policies should contact the chief editor of the journal. In cases where editors are unable to resolve a complaint, the journal may refer the matter to the authors’ funding institution and/or publish a formal statement of correction, attached online to the publication, stating that readers have been unable to obtain necessary materials to replicate the findings.”³³

Some journals have other conditions of publication that require authors to deposit specific information about their research (eg, metadata, results, or both) in a public repository or archive, although this is not data sharing per se. For example, following the recommendations of the ICMJE,³⁴ biomedical journals that publish clinical trials require authors to have registered their trials in approved, publicly accessible trial registries and to provide registration identifiers as a condition of publication (see 2.5.1, Structured Abstracts, and 19.3.6, Meta-analyses). In addition, many funders require authors to post articles that describe the results of their funded research in publicly available repositories, such as PubMed Central or Europe PubMed Central, and many journals make these deposits on behalf of authors (see 5.6.2, Public Access and Open Access in Scientific Publication).

Some journals require authors to provide data available on request for examination by the editors or peer reviewers (see 5.4, Ethical and Legal Considerations, Scientific Misconduct). For example, the JAMA Network journals require all authors to complete an authorship form that includes the following as part of their authorship responsibility statement:

If requested, I shall produce the data on which the manuscript is based for examination by the editors or their assignees.

In addition, for reports that contain original data (eg, research articles, systematic reviews, and meta-analyses), the JAMA Network journals require at least 1 author (eg, the principal investigator) to indicate that she or he “had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis” (see 5.5.5, Access to Data Requirement). The ICMJE supports this requirement.³⁴

With the aim to provide standards for journals, the Center for Open Science has produced a set of guidelines to promote transparency and openness in journal policies and practices.²¹ The guidelines provide 8 modular transparency standards that participating journals can adopt in part or in full and by which journals are ranked according to 3 levels of transparency. The standards include journals’ policies and requirements for the following²¹:

Citation of data and materials

Data transparency (eg, posting in an accessible repository)

Transparency of analytic methods and code

Transparency of research materials

Transparency of design and analysis for review and publication

Preregistration of studies

Preregistration of analysis plans

Encouragement of replication studies

5.6.1.4 Manuscripts Based on the Same Data.

On occasion, an editor may receive 2 or more manuscripts based on the same data (with concordant or contradictory interpretations and conclusions). If the authors of these manuscripts are not collaborators and the data are publicly available, the editor should consider each manuscript on its own merit (perhaps asking reviewers to examine the manuscripts simultaneously). Authors should attempt to resolve disputes over contradictory interpretations of the same data before submitting manuscripts to journals. When more than 1 manuscript is submitted by current or former coworkers or collaborators who disagree on the analysis and interpretation of the same unpublished data, the recipient editors are faced with a difficult dilemma. In such cases, the ICMJE recommends the following³⁴:

If editors receive manuscripts from separate research groups or from the same group analyzing the same data set (for example, from a public database, or systematic reviews or meta-analyses of the same evidence), the manuscripts should be considered independently because they may differ in their analytic methods, conclusions, or both. If the data interpretation and conclusions are similar, it may be reasonable although not mandatory for editors to give preference to the manuscript submitted first. Editors might consider publishing more than one manuscript that overlap in this way because different analytical approaches may be complementary and equally valid, but manuscripts based upon the same dataset should add substantially to each other to warrant consideration for publication as separate papers, with appropriate citation of previous publications from the same dataset to allow for transparency.

Secondary analyses of clinical trial data should cite any primary publication, clearly state that it contains secondary analyses/results, and use the same identifying trial registration number as the primary trial and unique, persistent dataset identifier.

Secondary analyses of any studies should always fully describe and cite the original research and publication and explain any overlapping or previously reported data (see 5.3, Duplicate Publication and Submission).

5.6.1.5 Record Retention Policies for Journals.

Journals should develop and implement consistent policies for retention of records and data related to the content that they publish. Legal documents (eg, copyright transfers, publication licenses, and permissions) should be kept indefinitely. All other records should be kept for a consistent, defined period. For example, the JAMA Network journals retain electronic copies of rejected manuscripts, correspondence, and reviewer comments up to 1 year to permit consideration of appeals of decisions. Electronic copies of accepted manuscripts and related correspondence and reviews are kept for 3 years. Journals also should develop consistent policies for the retention of online metadata associated with manuscript submissions, authors, and peer reviewers. For example, the JAMA Network journals retain metadata on manuscript submissions, decisions, and processing and milestone dates indefinitely to permit monitoring and reporting of key performance indicators and trends for individual journals (see 5.7.3, Confidentiality in Legal Petitions and Claims for Privileged Information). The ICMJE recommends the following³⁴:

When a manuscript is rejected, it is best practice for journals to delete copies of it from their editorial systems unless retention is required by local regulations. Journals that retain copies of rejected manuscripts should disclose this practice in their Information for Authors.

When a manuscript is published, journals should keep copies of the original submission, reviews, revisions, and correspondence for at least three years and possibly in perpetuity, depending on local regulations, to help answer future questions about the work should they arise.

5.6.2 Public Access and Open Access in Scientific Publication.

The open access movement began in the late 1990s in conjunction with technologic advances and calls for greater transparency in and availability of scientific information and following the proliferation of online journals available (both versions of print journals and journals published only online), the concurrent inability of declining library budgets to keep pace with increases in the numbers of journals and rising subscription prices, and demands to reduce information gaps and access to the results of funded research.^{35,36,37,38,39} Broadly defined, open access is the free and unrestricted online availability of content.³⁷ In its most liberal application, open access publishing means that users have unrestricted access without typical copyright restrictions and can freely read, download, copy, distribute, print, search, or link to full text of articles, as well as reuse and modify such content in part or whole for any lawful purpose provided that authors are properly acknowledged and cited.^40,41 Public access is the free access to content and typically permits users to read, download, print, search, and link to content, but with some copyright restrictions or limitations on sharing and reuse.⁴¹ Many funders require authors of funded research to publish articles as public access (eg, US National Institutes of Health)⁴² or open access (eg, Wellcome Trust).⁴³

There are 2 types of open access and within them several models: self-archiving (sometime called green open or public access) and open access publishing (eg, gold open access and hybrid open access). Self-archiving is the deposition of content in an open archive (ie, repository), sometimes before formal publication or after publication. PubMed Central is a public repository that archives full text of articles published in the biomedical and life sciences. In addition, many academic and commercial institutions and funders have their own archives or repositories. However, posts of articles in these repositories may not necessarily be open access; they may be posted for public access with limitations on reuse.

Preprint servers permit the posting and archiving of manuscripts before and after formal peer review and publication in a journal. A preprint is a complete manuscript that authors post to an open preprint server before publication in a journal. The preprint manuscript may be amended or updated, commented on by others, and remains on the preprint server even if subsequently published in a peer-reviewed journal. The first preprint server, arXiv, began in 1991 for the physics community. Since then, many preprint servers for other disciplines have been launched, including bioRxiv for biology and life sciences in 2013 and medRxiv for health sciences in 2019. Concerns have been expressed that self-archiving before peer review and publication may pose problems for version and quality control (eg, users may not understand the difference between an article that has not undergone peer review, revision, and editing and one that has undergone such measures to improve quality). Moreover, concerns have been raised that the posting of preprints in medicine “could lead to wide dissemination of inaccurate and potentially harmful clinical and public health information and to researchers pursuing hypotheses that are subsequently found to lack proper grounding, thereby erasing any gains made from the rapid dissemination of results.”⁴⁴ However, medical and health preprints are increasing with a growing number of funders and journals accepting preprints, and some journals offering simultaneous submission with posting of manuscripts to preprint servers.

In open access publishing, all or part of a journal is freely open to unrestricted use and perhaps unfettered reuse. This may or may not include the data that support specific types of articles (eg, research reports). The funding model for open access publishing requires author, institution, or funding agency payments, a subsidy from the owner or publisher, and/or external grants. Open access payments for publication are called article processing charges (APCs) (also known as article publication charges). The open access financial model differs from the traditional journal publishing model, in which publication and sustainability of the publishing enterprise are based on revenue from paid subscriptions, advertising, licensing, royalties, reprints, and other forms of revenue. There are different models of open access^40,41 and a variety of practices within each model.

Gold open access: journals make all content freely available from the time of publication, which is typically (but not always) funded by APCs and no individual or institutional subscription, permission, or access/reuse fees (however, other sources of revenue may be available, such as via institutional agreements, grants, and advertising).

Diamond open access: a form of gold open access that does not include a requirement for authors to pay APCs.

Hybrid open access: journals with a traditional paid subscription-based economic model that offer authors of articles the option to pay a fee (APC) for immediate open access.

Delayed public access: journals with a traditional paid subscription-based economic model make research articles free public access without any author fees (often a delayed period, such as 6-12 months before the article is made free public access). Note: This model is not open access.

Although a few journals were published in an open access model before the 1990s, most open access journals began publication after the year 2000, when BioMed Central (BMC) launched a series of open access journals that were peer reviewed but did not undergo editorial revision and editing. In exchange for an APC payment, research articles were made immediately free open access at the time of publication. In addition, individual organizations, such as universities, could purchase a membership at a significantly greater collective fee (through prepaid or bulk-paid APCs), allowing their author-employees or affiliated authors to publish in BMC journals without having to pay the author publication fees for individual articles. In 2019, BMC, owned by Springer Nature, published more than 300 open access journals, with most journals charging APCs (varying in price from US$860 to $3680) in exchange for immediate open access to the full text of published articles.⁴⁵ BMC now indicates that the APCs cover peer review and a range of publishing services, including “provision of online tools for editors and authors, article production and hosting, liaison with abstracting and indexing services, and customer services.”⁴⁶

In 2003, PLOS launched its first in a series of open access journals with an initial $9 million grant from the Moore Foundation.⁴⁷ In addition to grants, journal operations were funded by APCs: in 2003 the author fee was $1500 to publish an article; in 2006 the fee was increased to $2500. By 2010, PLOS reported that it was financially self-sufficient based on the APC model, and in 2017 APCs ranged from $1595 to $3000.⁴⁸ During this time, PLOS launched one of the first mega journals. A mega journal “publishes freely accessible articles, which have been reviewed for scientific trustworthiness, but leaves it to the readers to decide which articles are of interest and importance to them.”⁴⁹ These journals rely on large numbers of submissions and high acceptance rates. PLOS ONE launched in 2010 and published 6913 articles that year; in 2014 the journal published 30 054 articles, and the acceptance rate was 69%.⁴⁹ Since then, the number of articles, although still very high, published by PLOS ONE has declined annually as other mega journals (eg, Scientific Reports) have entered the market and more journals have offered open access options.⁵⁰

An unanticipated exploitative outcome of open access publishing has been the swift rise of predatory journals that charge authors APCs to publish in journals of dubious reputation or experience and without peer review, editorial, or publishing services.⁵¹ In some cases, authors are unaware of the deceptive nature of these journals and are duped by journal titles that resemble prominent quality journals. In other cases, authors deliberately use these dubious journals to publish articles quickly without peer review or quality checks or to build a citation ladder and later cite these articles in genuine journals to make their research appear more credible than it is. These deceptive journals have proliferated, causing concerns about the integrity of scientific scholarship as they have permeated authentic electronic databases.⁵² By 2014 an estimated 8000 predatory journals were reported to have published an estimated 420 000 articles.⁵³

A number of traditional journals (published by academic societies and/or commercial publishers) offer hybrid open access options to permit authors to comply with funder mandates for open access. Between 2015 and 2017, the numbers of fully open access journals increased by 11%, hybrid journals increased by 17%, and subscription-only journals decreased by 37%.⁵⁴ Open access advocates and some funders require authors to publish in fully open access journals.

The Directory of Open Access Journals was launched in 2003 with 300 open access (gold) journals.⁵⁵ In July 2019, the Directory of Open Access Journals listed 13 500 journals that have published more than 4.1 million articles.⁵⁵ Advocates of open access publishing cite the benefits of widespread dissemination of research: universal access, enhanced global collaboration, improved transparency of research, and the belief that open access articles will be read, used, and cited more frequently than articles published in traditional journals with access controls.^{35,37,38,43,45} Others express concern about the quality of literature published in a system that may favor those who pay or that uses limited peer review and editorial curation and raise other concerns, such as unfairness of the author-pays model for researchers with limited funds, confusion about evolving policies among authors and journals, risk for exploitation of researchers and authors, risk of unfettered commercial reuse, and risks to the financial stability of journals with business models based on more diversified, traditional sources of revenue and to their owners.^{39,40,50,51,52,53}

Coupled with the open access movement, in 2005 funding agencies (eg, NIH and the Wellcome Trust) began requesting or requiring funded investigators to permit articles that describe results of their funded research to be posted in publicly accessible repositories (such as PubMed Central).^42,43 Negotiations between these agencies and publishers resulted in another form of access: delayed public access.²⁶ In this model, which has been in wide use by scientific and biomedical publishers (especially those owned by not-for-profit professional societies) for many years, research articles are made freely available after a defined interval, such as 6 months, 1 year, or 2 years. The interval, which may be influenced by the frequency of journal publication, is intended to protect subscription, licensing, advertising, and other traditional forms of journal revenue.

Many journals offer authors a range of public access and open access options, with and without fees, including public access for research articles after a specified time without author fees, immediate open access for research articles or all articles based on APCs and perhaps other processing or publication fees, permitting deposits in public repositories with a specified delay or without such delay, and permitting self-archiving in authors’ individual or institutional repositories. Open access publishing models are proliferating with some funder mandates threatening traditional publishing models, and debate continues over which models might be sustainable in the long term.^40,41,56 Each model has advantages and disadvantages. A combination of models may be appropriate for publishers and journals that seek to balance the advantages of open access with the financial requirements of sustainable, quality publication.

In addition, journals and funders are developing and experimenting with different publication licenses in lieu of standard copyright transfers to permit various access and use rights for articles published under public access and open access models. According to the Association of Learned and Professional Scholarly Publishers (ALPSP), although many publishers still require some form of copyright transfer, the proportion of small and large publishers that use publication licenses increased from 15% and 17%, respectively, in 2005 to 18% and 40%, respectively, in 2012⁵⁷ (see 5.6.5, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Copyright Assignment or License). A subsequent survey of 240 publisher members of ALPSP in 2015 reported that 80% of publishers continued to rely on a subscription or content licensing business model, with 83% also offering some form of APC option that included use of a publication license (69% had hybrid open access journals and 17% had fully open access journals).⁵⁸ These models continue to evolve.

In parallel with the open access movement, Creative Commons (CC), a nonprofit organization, was created in 2001 and developed copyright licenses known as CC licenses that are intended to permit a wide range of permissions, sharing, and reuse without fees and often without individual point-of-use permissions.⁵⁹ Six copyright license types are available, ranging from Attribution (CC BY) to Attribution-NonCommercial-NoDerivs (CC BY-NC-ND). The CC BY license permits others to copy, distribute, transform, and build on work for any purpose, even commercially, as long as they credit the original creator. This is the most liberal of the 6 licenses and is recommended for maximum dissemination and use of licensed materials. The CC BY-NC-ND license, which is the most restrictive of the CC licenses, permits others to download works and share them as long as they credit the original creator but does not permit alteration or commercial reuse of the work without additional permission. Additional information is available on the Creative Commons website⁵⁹ (see 5.6.5, Copyright Assignment or License).

5.6.3 Copyright: Definition, History, and Current Law.

Copyright is a term used to describe the legal right of authors to control the communication and reproduction of their original works of authorship, and in the United States, it has its basis in the US Constitution.^1,16 Copyright law provides for the protection of rights of parties involved in the creation and dissemination of intellectual property. While a variety of people and entities derive benefits from copyright laws (authors, publishers, editors, composers, artists, and the producers of video and audio broadcasts and programs, films, websites, computer programs, applications, and software), few thoroughly understand the law and its basic applications. This section discusses current copyright laws and applications in scientific publishing. Copyright laws, scope, and protections vary by country (see 5.6.11, International Copyright Protection). The discussion in this section addresses US copyright law except where specifically indicated. This section is intended to explain copyright law as it applies to scientific publication; it is not intended to serve as legal advice. A media lawyer should be consulted for any specific concerns about rights, protections, infringements, or remedies.

Copyright is a form of legal protection provided to the author of published and unpublished original works.^{16(§102,§104),60,61} The author, or anyone to whom the author transfers copyright, is the owner of copyright in the work. Current law gives the owner of copyright the following exclusive rights^{16(§102,§103)}:

■To reproduce the work in copies

■To prepare derivative works based on the copyrighted work

■To distribute, perform, or display the work publicly

A copyrightable work must be fixed in a tangible medium of expression and includes the following^16(§102),62:

■Literary works (which include computer software and works produced in digital formats)

■Musical works, including any accompanying words

■Dramatic works, including any accompanying music

■Pantomimes and choreographic works

■Pictorial, graphic, and sculptural works

■Motion pictures and other audiovisual works

■Sound recordings

■Architectural works

The following are not protected by copyright, although they may be covered by patent and trademark laws^{16(§102),60,63} (see 5.6.14, Patents, and 5.6.15, Trademark):

■Ideas, methods, and systems. Examples include

Inventions (inventions meeting certain requirements may be patentable)

Recipes

■Names, titles, and short phrases. Examples of names, titles, or short phrases that do not contain a sufficient amount of creativity to support a claim in copyright include

The name of an individual (including pseudonyms, pen names, or stage names)

The title or subtitle of a work, such as a book, a song, or a pictorial, graphic, or sculptural work

The name of a business or organization

The name of a band or performing group

The name of a product or service

A domain name or URL

The name of a character

Catchwords or catchphrases

Mottos, slogans, or other short expressions

■Typeface, fonts, and lettering

■Blank forms. Examples of blank forms include

Time cards

Graph paper

Account books

Diaries

Bank checks

Scorecards

Address books

Report forms

Order forms

Date books and schedulers

■Familiar symbols and designs. Examples of familiar symbols and designs include but are not limited to

Letters, punctuation, or symbols on a keyboard

Abbreviations

Musical notation

Numbers and mathematical and currency symbols

Arrows and other directional or navigational symbols

Common symbols and shapes, such as a spade, club, heart, diamond, star, yin and yang, or fleur-de-lis

Common patterns, such as standard chevron, polka dot, checkerboard, or houndstooth

Well-known and commonly used symbols that contain a minimal amount of expression or are in the public domain, such as the peace symbol, gender symbols, or simple emoticons

Industry designs, such as the caduceus, barber pole, food labeling symbols, or hazard

Warning symbols

Familiar religious symbols

Common architecture moldings

Some of the more common provisions of US copyright law as well as problems encountered by scientific authors, editors, and publishers are discussed in sections 5.6.4 through 5.6.10.

5.6.3.1 History of Copyright Law.

Copyright law evolved after Gutenberg’s movable type reduced the cost and labor required to make copies of written and printed works.^1,62,64 During the early 18th century, copyright became the mediator between the author or publisher and the marketplace. In 1710, England created the Statute of Anne, the first copyright act, which addressed exact copies only. Article I, section 8, of the US Constitution, enacted in 1798, serves as the foundation for US copyright law, which grants the US Congress the power to “promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”^65,66 Since then, the US law has undergone a number of updates and general revisions in response to innovations and changes in technology, to broaden the definition and scope of copyright law, and to address mechanisms for protection among different countries.^16,66 In 1790, the United States created the first copyright law to cover magazines and books, but again, this was only for exact copies. During the 19th century, copyright law was extended to translations, works made for hire, music, dramatic compositions, photography, and works of art. During the 20th century, copyright law was extended to cover motion pictures, performance and recording of nondramatic literary works, sound recordings, computer programs, and architectural works. The US Copyright Act of 1909 added formal requirements to ensure protection, such as use of copyright notice, official registration, and renewal of copyright terms.⁶⁶

5.6.3.2 US Copyright Act of 1976.

Before 1978, 2 systems of copyright coexisted in the United States. Common law copyright, regulated by individual states, protected works from creation until publication, and a separate federal law protected works from publication until 28 years thereafter (with an option for a 1-time renewal of the 28-year term).^16,60 The Copyright Act of 1976, which became effective January 1, 1978, contained the first major revisions of US copyright law in almost 70 years. This act, reversing many of the formalities required by the 1909 act, remains in force today. Thus, for all works created after 1978, current law automatically provides protection to the creator of the work at the time it is created, whether written, typewritten, or entered into a computer, whether the work is published or not, and whether the work bears a copyright notice. In addition, the 1976 act changed the terms of copyright duration, with most terms equaling the life of the author plus 50 years. In 1998, the term of copyright protection for most works was extended to the life of the author plus 70 years^16,66 (see 5.6.4, Types of Works and Copyright Duration in the United States).

5.6.3.3 International Conventions and Treaties.

In 1886, the Berne Convention was created by 10 European nations to protect copyright across national boundaries. The United States did not sign on to the Berne Convention until 1989.^16,67 The Universal Copyright Convention (UCC) was adopted in 1952 as an alternative for countries that disagreed with some aspects of the Berne Convention. A number of conventions and treaties adopted in the 1990s address copyright as it has been affected by new economic, social, cultural, and technological developments and by new international rules, including the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), World Intellectual Property Organization (WIPO) Copyright and Performances and Phonograms Treaty, and the WIPO Copyright Treaty.^66,67 For more details, see 5.6.11, International Copyright Protection.

5.6.3.4 Copyright and New Technology.

Throughout the 20th and 21st centuries, technological advances have challenged copyright law, including photographs, motion pictures, radio, television, photocopying, cable television, computers, databases, multimedia, and the internet.^1,61,64 The most recent challenge began in the 1990s with the increase of electronic publishing and new media. Although copyright law was designed to be technology neutral, it applied only to tangible copies and to the physical distribution of these copies. Although early users of the internet sent email messages and posted information on electronic mailing lists and bulletin boards without much concern for ownership and copyright of their communications, editors and publishers became concerned about maintaining the integrity, quality, and ownership of their intellectual property once content was easily and widely digitized, published, and transmitted electronically.

In 1998, the US Digital Millennium Copyright Act (DMCA) was enacted to extend copyright protection to works created in a digital medium.¹⁶ Interpreting the DMCA, Hart notes that “works created in digital media are considered ’fixed’ if they can be perceived, reproduced, or otherwise communicated for more than a transitory period, including the fixation on a computer disc or in a computer’s random access memory.”^61(p190) Among its major provisions, the DMCA implements the WIPO treaties; limits certain liability of online service providers that adhere to specific requirements through safe-harbor provisions; limits liability of libraries and archives; prohibits the circumvention of technological barriers designed to control access to content (anticircumvention); establishes penalties for such circumvention; addresses works now available through new technologies, such as distance education audio, video, and webcasts; and preserves existing rights of copyright owners.^16,61

Since its enactment, the DMCA has addressed concerns about copyright protection and infringement in electronic publishing. However, continuing rapid advances in technology foretell future changes in copyright law, requiring the publishing community to be alert to such changes for the foreseeable future.

5.6.4 Types of Works and Copyright Duration in the United States.

The length of copyright protection in the United States depends on several factors: when the work was created (key dates are before or after January 1, 1978), the number of authors (ie, single-author vs joint-author works), and the type of work (eg, work made for hire or owned by the federal government).^68,69 See Table 5.6-1 for examples of types of works, conditions, and terms of copyright protection.⁶⁸

5.6.4.1 Works Created After 1978.

To be protected by copyright law, a work must be original. For works created by a single author, copyright belongs to that author from the instant of its creation and for 70 years after the author’s death.^{16(§302),68,69} See Table 5.6-1 for details on other conditions and terms and 5.6.4.3, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Types of Works and Copyright Duration in the United States, Joint Works by 2 or More Authors, and 5.6.4.4, Types of Works and Copyright Duration in the United States, Works Made for Hire.

5.6.4.2 Works Created Before 1978.

Several different rules apply to works created before 1978 and depend on whether the work was published, previous copyright duration terms, and whether the copyright has been renewed (Table 5.6-1).^68,69 For example, as of 2019, unpublished works created before 1978 are protected for the life of the author plus 70 years. Works published between 1924 and 1977 are protected for 95 years after date of publication provided that a copyright notice was published and appropriate renewals were made^68,69 (see 5.6.6, Copyright Notice and Registration). Works that were published before 1924 are now in the public domain.

Table 5.6-1. Copyright Term and the Public Domain in the United States, as of 2019^a

^a This table was adapted and reproduced from Copyright Term and the Public Domain in the United States. ©2004-2019 Peter B. Hirtle, under Creative Commons Attribution 3.0 License.⁶⁸ It was first published in Peter B. Hirtle, "Recent Changes To The Copyright Law: Copyright Term Extension," Archival Outlook, January/February 1999. This version is current as of January 1, 2019. The most recent version is found at https://copyright.cornell.edu/publicdomain. Additional information for works published outside of the United States and for sound recordings can also be found at this site. For some explanation on how to use the table and complications hidden in it, see Peter B. Hirtle, "When Is 1923 Going to Arrive and Other Complications of the US Public Domain," Searcher (September 2012). The table is based in part on Laura N. Gasaway’s chart, "When Works Pass Into the Public Domain," at http://www.unc.edu/~unclng/public-d.htm, and similar charts found in Marie C. Malaro, A Legal Primer on Managing Museum Collections Smithsonian Institution Press; 1998:155-156). A useful copyright duration chart by Mary Minow, organized by year, is found at http://www.librarylaw.com/DigitizationTable.htm. A flowchart for copyright duration is found at http://sunsteinlaw.com/practices/copyright-portfolio-development/copyright-pointers/copyright-flowchart/, and a tree-view chart on copyright is at http://chart.copyrightdata.com. Several US copyright duration calculators are available online, including the Public Domain Sherpa (http://www.publicdomainsherpa.com/calculator.htm) and the Durationator (in beta at http://www.durationator.com/). Europeana’s public domain calculators for 30 different countries outside of the United States (at http://www.outofcopyright.eu/). The Open Knowledge Foundation has been encouraging the development of public domain calculators for many countries: see http://publicdomain.okfn.org/calculators/. See also Library of Congress Copyright Office. Circular 15a, Duration of Copyright: Provisions of the Law Dealing with the Length of Copyright Protection (Library of Congress; 2004) at http://www.copyright.gov/circs/circ15a.pdf. Further information on copyright duration is found in chapter 3, "Duration and Ownership of Copyright," in Copyright and Cultural Institutions: Guidelines for Digitization for US Libraries, Archives, and Museums, by Peter B. Hirtle, Emily Hudson, and Andrew T. Kenyon (Cornell University Library; 2009), available for purchase at http://bookstore.library.cornell.edu/ and as a free download at http://ecommons.cornell.edu/handle/1813/14142.

^b Treat unpublished works registered for copyright prior to 1978 as if they had been published in the United States (though note that the only formality that applied was the requirement to renew copyright after 28 years). Unpublished works registered for copyright since 1978 can be considered as if they were an "unpublished, unregistered work."

^c All terms of copyright run through the end of the calendar year in which they would otherwise expire, so a work enters the public domain on the first of the year following the expiration of its copyright term. For example, a book published on March 15, 1923, entered the public domain on January 1, 2019, not March 16, 2018 (1923 + 95 = 2018).

^d Unpublished works when the death date of the author is not known may still be copyrighted after 120 years, but certification from the Copyright Office that it has no record to indicate whether the person is living or died less than 70 years before is a complete defense to any action for infringement (see 17 USC §302[e]).

^e Presumption as to the author’s death requires a certified report from the Copyright Office that its records disclose nothing to indicate that the author of the work is living or died less than 70 years before.

^f “Publication” was not explicitly defined in the Copyright Law before 1976, but the 1909 act indirectly indicated that publication was when copies of the first authorized edition were placed on sale, sold, or publicly distributed by the proprietor of the copyright or under his authority.

^g Not all published works are copyrighted. Works prepared by an officer or employee of the US government as part of that person’s official duties receive no copyright protection in the United States. For much of the 20th century, certain formalities had to be followed to secure copyright protection. For example, some books had to be printed in the United States to receive copyright protection, and failure to deposit copies of works with the Register of Copyright could result in the loss of copyright. The requirements that copies include a formal notice of copyright and that the copyright be renewed after 28 years were the most common conditions and are specified in the Table.

^h A 1961 Copyright Office study found that fewer than 15% of all registered copyrights were renewed. For books, the figure was even lower: 7%. See Ringer B. Study No. 31: renewal of copyright. In: Copyright Law Revision: Studies Prepared for the Subcommittee on Patents, Trademarks, and Copyrights of the Committee on the Judiciary, United States Senate, Eighty-sixth Congress, First [-Second] Session. US Government Printing Office; 1961:220. A good guide to investigating the copyright and renewal status of published work is Demas S, Brogdon JL. “Determining Copyright Status for Preservation and Access: Defining Reasonable Effort. Library Resources and Technical Services 1997;41(4):323-334. See also Library of Congress, Copyright Office. Circular 22: How to Investigate the Copyright Status of a Work. Library of Congress, Copyright Office; 2004 (http://www.copyright.gov/circs/circ22.pdf). The Online Books Page FAQ (http://onlinebooks.library.upenn.edu/okbooks.html), especially "How Can I Tell Whether a Book Can Go Online?" and "How Can I Tell Whether a Copyright Was Renewed?" is also helpful.

ⁱ Contractors and grantees are not considered government employees. Generally, they create works with copyright (although the government may own that copyright). See CENDI Frequently Asked Questions About Copyright: Issues Affecting the US Government (http://www.cendi.gov/publications/04-8copyright.html). The public domain status of US government works applies only in the United States.

5.6.4.3 Joint Works by 2 or More Authors.

A joint work is a work prepared by 2 or more authors with the intention that their contributions be merged into inseparable or interdependent parts of a unitary whole. For such works, the 70-year term begins after the death of the last surviving author.^16(§302)

5.6.4.4 Works Made for Hire.

Works created by an individual who is paid by another specifically for such work are covered by a particular provision of the copyright statute. In these cases, the law recognizes the employer or the party contracting for the work as the owner of the copyright in the work. Works made for hire generally fall into 2 categories.^16(§101),70 The first category is a work prepared by an employee within the scope of her or his employment duties, such as a journal editorial written by an editor who is employed by or otherwise contracted to work as an editor by the journal’s owner. The second category comprises certain specially ordered or commissioned works. Examples include a news story written by a freelance journalist or an index prepared by an individual under contract. In these cases, although a formal copyright assignment is not necessary, the parties must sign an agreement before the work is produced specifying that the work is to be a work made for hire. Copyright duration for works made for hire is 95 years from the year of first publication or 120 years from the date of the work’s creation, whichever is shorter.^16(§302)

5.6.4.5 Works Created by Anonymous and Pseudonymous Authors.

The same terms of copyright duration that apply to works made for hire apply to works published by anonymous or pseudonymous authors—95 years from the year of first publication or 120 years from the date the work was created, whichever is shorter. If 1 or more authors’ names are disclosed and registered with the US Copyright Office before the 95-year or 120-year term expires, the term changes to 70 years after the last surviving author’s death^16(§302),69 (see 5.1.3, Unsigned Editorials, Anonymous Authors, Pseudonymous Authors).

5.6.4.6 Works in the Public Domain or Created by the US Government.

A work is in the public domain if it has failed to meet the requirements of copyright protection or its copyright protection has expired. Works in the public domain may be used freely by anyone without permission. US works published before 1924 are now in the public domain.⁶⁸ In 2015, the Project Gutenberg website included more than 58 000 books that were considered free to use, mostly because copyright had expired.⁷¹ Works created by US federal government employees in the course of their employment are also in the public domain^16(§105) (see 5.6.1, Ownership and Control of Data, and 5.6.5.3, Exception—Works Created by Employees of the US Federal Government or That of Other Nations). However, works produced by state and local governments are subject to copyright protection.

Works created by other national governments are subject to the copyright laws of their respective countries and perhaps the Berne Convention, WIPO Copyright Treaties, or other international treaties (see 5.6.11, International Copyright Protection).

5.6.4.7 Collective Works.

A collective work comprises a number of independent contributions (usually from many authors), which constitute separate and independent works in themselves, and are assembled into a collective whole. Examples of collective works include periodicals, such as journals, magazines, multiauthored textbooks, and encyclopedias.^16(§101) Copyright in the independent contributions is separate from copyright in the collective work as a whole and initially belongs to the individual authors until they transfer copyright to the owner of the collective work, usually a publisher. Publishers that require authors of collective works (such as authors of a journal article) to transfer copyright or a publication license should require such transfer from each author, not just the corresponding author. Editors of collective works may also be required to transfer copyright assignment or a publication license if their contributions are not already covered under work for hire or other employment agreements. Thus, both the individual articles (independent works) and the journal (collective work) can be protected by copyright.

5.6.4.8 Compilations and Derivative Works.

According to US copyright law, compilations are works “formed by the collection and assembling of preexisting materials or data that are selected, coordinated, and arranged in such a way that the resulting work as a whole constitutes original work of authorship.”^16(§101) The term compilation includes collective works (see 5.6.4.7, Types of Works and Copyright Duration in the United States, Collective Works). Examples of compilations include a compendium of previously published articles on a specific theme or topic or a collection of abstracts. The basis for protection of a compilation is the judgment required to select and arrange the material.⁶² In this context, the 1991 US Supreme Court ruling in Feist Publications Inc v Rural Telephone Service Co Inc is worth noting.⁷² In that case, a regional telephone company used a local telephone company’s directory without its permission. The local company sued for copyright infringement and lost. The court held that the “data” in the directory (collections of public telephone numbers) had no substantial originality or creativity and that comprehensive collections of data arranged in conventional formats do not merit copyright protection.⁷²

Derivative works are those based on 1 or more preexisting works, such as a translation, abridgment, condensation, or republication in a different format, language, or media.^16(§101) Examples of derivative works include revised editions of books or articles that are republished, translated, or annotated individually or collected and republished in print and/or online.

Scientific journal publishers typically request that authors transfer broad rights to their work in the form of a copyright transfer or exclusive license or a nonexclusive license that includes rights to produce compilations and derivative works. Such publishers often receive royalties from the distribution and sale of compilations and derivative works. In addition, publishers who own copyright or have exclusive licenses in individual articles are legally able to address misuse or piracy of such works (see 5.6.2, Public Access and Open Access in Scientific Publication).

5.6.4.9 Revised Editions.

A revised edition of a previously copyrighted work may be regarded as a separately copyrighted work if there is substantial original new work in the new edition. The Chicago Manual of Style defines substantial as change that occurs in 1 or more of the essential elements of the work, such as text, notes, appendixes, or tables and illustrations (if they are integral to the work), and notes that generally at least 20% of a new edition should consist of new or revised material.^73(§1.26) Thus, a new foreword or preface, the addition of a few references, or corrections to the original text do not constitute a revised edition, but they may be included in subsequent printings with an explanation on the copyright notice page. For example, this edition of the AMA Manual of Style constitutes a major revision that results in a new copyrighted work. For revised editions, any unaltered material retained in a subsequent edition remains protected under the original copyright, and copyright applicable to the new material does not extend the duration of copyright in the old material.

The Chicago Manual of Style recommends that publishers use standard language to designate specific editions: 2nd edition, 3rd edition, 4th edition, and so on.^73(§1.26) If the new edition is simply printed in a different format, eg, in paperback or in a different language through a licensing agreement, the status can be designated as “Paperback edition 2005” or “French-language edition” (see 3.12.7, References to Books, Edition Number).

Some publishers list the various dates of revisions on the copyright page as a record of publishing history. The publishing history follows the copyright notice. For example, this manual has had 11 editions:

2020, AMA Manual of Style: A Guide for Authors and Editors, 11th ed (Christiansen et al)

2007, AMA Manual of Style: A Guide for Authors and Editors, 10th ed (Iverson et al)

1998, American Medical Association Manual of Style: A Guide for Authors and Editors, 9th ed (Iverson et al)

1989, American Medical Association Manual of Style, 8th ed (Iverson et al)

1981, Manual for Authors & Editors, 7th ed (Barclay et al)

1976, Stylebook/Editorial Manual of the AMA, 6th ed (Barclay)

1971, Stylebook/Editorial Manual of the AMA, 5th ed (Hussey)

1966, Stylebook and Editorial Manual, 4th ed (Talbott)

1965, Stylebook and Editorial Manual, 3rd ed (Talbott)

1963, Stylebook and Editorial Manual, 2nd ed (Talbott)

1962, Style Book (Talbott)

5.6.5 Copyright Assignment or License.

Typically, copyright of a work vests initially with the author of the work. As copyright owner, an author may transfer rights to a publisher by copyright assignment, exclusive license, or nonexclusive license.^16,64,73 A broadly worded exclusive license may provide much of the same rights to publishers as would a copyright transfer agreement. Thus, an owner of an exclusive assignment (through either copyright transfer or broadly worded exclusive license) may produce derivative works and sublicense specific rights to others. Some publishers permit authors to retain certain rights to their works, even when assigning copyright or granting an exclusive license (such as making copies for educational purposes, posting a copy on a personal or institutional website, or depositing a copy in an institutional or other repository to comply with research funding requirements). A nonexclusive license for publication permits a publisher certain rights to publish and disseminate work, but the copyright remains with the author, who retains control over access, use, and distribution.

Journals that offer open access publication may rely on nonexclusive copyright licenses that permit a range of access and reuse options, such as those created by Creative Commons (https://creativecommons.org).⁵⁹ The Creative Commons (CC) copyright licenses permit a wide range of permissions, sharing, and reuse without fees and often without individual point-of-use permissions.⁵⁹ Creative Commons has 6 types of copyright license, ranging from Attribution (CC BY) to Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) (see 5.6.2, Public Access and Open Access in Scientific Publication).

Publishers that have copyright or exclusive publication licenses also may grant others nonexclusive secondary-use licenses to use, reproduce, or disseminate content, and many grant authors the rights to post copies of research articles in approved public repositories or share copies with colleagues for noncommercial educational purposes (see 5.6.2, Public Access and Open Access in Scientific Publication). In addition, publishers may grant a 1-time nonexclusive licensee to reproduce a work in a specified manner (eg, permission to reprint or translate and distribute a specific article) (see 5.6.7, Copying, Reproducing, Adapting, and Other Uses of Content, and 5.6.9, Standards for Commercial Reprints and e-Prints).

Publishers that make substantial investments in their products may seek exclusive publication rights from authors. However, few visual artists or professional photographers will agree to such terms and more commonly grant nonexclusive rights to publishers who want to include their works. In addition, many institutions and scientific research funders encourage or require authors to transfer nonexclusive, open access, or other conditional rights of their work to publishers (see 5.6.5.4, Exception—Institutional Owners of Copyright, and 5.6.2, Public Access and Open Access in Scientific Publication). Journals that accept such limited conditional licenses need to be sure that they obtain licenses that cover all subsidiary rights that the publisher may want to exercise or sublicense (eg, online and licensed versions, reprints, e-prints, collections, and archival copies as well as versions in multiple languages and multiple types of media). Increasing demands by authors and their institutions and funders and the increasing complexity of publishing models portend much future debate among authors, institutions, and publishers with regard to copyright assignments, licenses, and publication (see 5.6.2, Public Access and Open Access in Scientific Publication).^{39,40,41,42,43,44,57,58}

Common arguments in favor of copyright transfer or publication license from authors to publishers include the following:

■The publisher must have the opportunity to publish or license the publication of the work in other forms to recoup or justify the expenses associated with the editorial and peer review, editing and quality assurance, publication, distribution, online hosting, indexing, and maintenance of the original work.

■The publisher, with business and legal expertise and resources, is better able to distribute and maintain the work in print and online, protect it from misuse and piracy, and take advantage of new technologies and media.

■The publisher is better equipped to invest in the work and take the risk that the work may not be successful.

■The publisher serves the author’s interest in promotion of the work and professional advancement.

Common arguments in favor of the author’s retention of copyright include the following:

■Authors who retain ownership of their works can distribute their works themselves, through their institutions, repositories, or other means, or via author-pay open access publication options.

■Authors who retain ownership of their works can help to limit the increasing subscription costs of scientific journals.

■Authors deserve to receive financial reward from both the original publication and any subsequent republication or dissemination.

■Authors’ retention of copyright meets the traditional need for identification of intellectual ownership.

■New technology enables misuse and theft of intellectual property and obviates the ability of publishers to protect copyright, perhaps rendering copyright obsolete.

5.6.5.1 Assignment of Copyright or License as a Condition of Publication.

As a condition of considering a work for publication, publishers of biomedical and scientific journals require authors to transfer copyright or an exclusive publication license or assert a CC publication license (often used with author-pay for open access publications) in the event that the work is published. This requires authors to complete a publishing agreement indicating the transfer of copyright or a publication license to the publisher. Since the transfer of copyright or publication license may not actually occur until the work is published, editors may choose to consider manuscripts submitted without a statement of copyright transfer or publication license from the author and then ask for it if a revision is requested or the manuscript is to be accepted. In the event that the work is published, the author agrees to transfer copyright or a publication license to the journal, publisher, or owner. If the work is not published, the copyright then remains with the author.

For example, the JAMA Network journals require all authors (including each coauthor) to complete a copyright transfer or publication license statement:

Copyright Transfer. In consideration of the action of the American Medical Association (AMA) in reviewing and editing this submission (manuscript, tables, figures, audio, video, and other supplemental files submitted for publication), I hereby transfer, assign, or otherwise convey all copyright ownership, including any and all rights incidental thereto, exclusively to the AMA, in the event that such work is published by the AMA.

Authors of articles published in JAMA Network journals who elect to pay for an open access CC BY license complete the following publication license transfer statement:

Publication License. In consideration of the action of the American Medical Association (AMA) in reviewing and editing this submission (manuscript, tables, figures, audio, video, and other supplemental files submitted for publication), I hereby transfer, assign, or otherwise convey first publication rights exclusively to the AMA, in the event that such work is published by the AMA, in addition to the attributes of a CC BY License.

Note: For both of these assignments, there are exceptions and different statements for authors who are employed by the US federal or other national government or who authored a work under a work for hire agreement (see 5.6.5.3, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Copyright Assignment or License, Exception—Works Created by Employees of US Federal Government or That of Other Nations, and 5.6.5.4, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Copyright Assignment or License, Exception—Institutional Owners of Copyright).

5.6.5.2 Assignment by Coauthors.

The authors of a joint work are co-owners of copyright in the work. To transfer copyright or grant a publication license in a joint work, the copyright assignment or license must be signed by each of the authors.

5.6.5.3 Exception—Works Created by Employees of the US Federal Government or That of Other Nations.

Because copyright does not vest in works created by the US federal government, no assignment from the author is necessary.^16(§105) However, journals should obtain a signed statement from each author who contributed to a work as a federal government employee. What constitutes a work of a government employee as part of the person’s official duties is not always clear, but generally, the application of the federal employee exception is determined by the nature of the author rather than the nature of the work or its funding. Works created by authors of other national governments may be subject to the copyright laws of their respective countries.

For example, the JAMA Network journals require all authors who contribute to a work as part of their duties as an employee of the US federal government or that of another nation to complete the following statement:

Federal Employment: I was an employee of the US federal government or that of another nation when this work was conducted and prepared for publication; therefore, it is not protected by the Copyright Act, and copyright ownership cannot be transferred.

or

Federal Employment: I was an employee of the US federal government or that of another nation when this work was conducted and prepared for publication; therefore, it is not protected by the Copyright Act, and a publication license cannot be transferred.

When some authors of a joint work contributed as employees of the US federal government or that of another nation and other authors did not, each government-employed author must complete the federal employment statement and all other authors must use the standard copyright transfer agreement.

5.6.5.4 Exception—Institutional Owners of Copyright.

On occasion, a manuscript from an author or authors from a single institution may be submitted with a copyright transfer or publication license and completed on behalf of the institution rather than by the individual authors. The institution presumably has an agreement with the authors, following the work for hire provision of the copyright law, that all work performed while the authors are employees of the institution is owned by the institution. Accordingly a representative of the institution may transfer copyright or grant a publication license (see 5.6.4, Types of Works and Copyright Duration in the United States, and 5.6.4.4, Types of Works and Copyright Duration in the United States, Works Made for Hire).

For example, the JAMA Network journals provide the following work for hire statement:

Work for Hire. I am employed by an institution that considers this submission a “work made for hire” and that requires an authorized representative of the institution to assign copyright [or publication license] on my behalf.

The JAMA Network journals then require an institutional representative to complete copyright, or publication license, transfer on behalf of the author(s).

Scientific journals should be cautious about accepting limits on copyright transfers or publication licenses from institutions or commercial entities that could remove the journal’s ability and authority to approve subsequent uses of a journal article, and the journal’s imprimatur of that article, for commercial or promotional purposes. Journals also need to avoid the possibility of commercial or exploitative use of a work in a manner deemed unsuitable by the journal.

5.6.6 Copyright Notice and Registration.

Although use of a copyright notice is not required under copyright law, the US Copyright Office strongly recommends use of such a notice.⁶⁰ A copyright notice for all visual copies of a work should contain the following 3 elements^16(§401):

The word “Copyright,” the abbreviation “Copr,” or the symbol ©,

The year of first publication of the work, and

The name of the copyright owner.

Examples:

Copyright 2019 American Medical Association

© 2019 American Medical Association

Note: For the JAMA Network journals, the wording above includes the name of the owner of the journals (American Medical Association) not the name of the journal. It is recommended that all copyright notices be placed in such a “manner and location as to give reasonable notice of the claim of copyright.”^16(§401),60 The wording and placement of copyright notices applies equally to print and online works.

The JAMA Network journals include the copyright notice with every article (in print and online) or in the Article Information section for open access licenses.

Example:

Open Access: This is an open access article distributed under the terms of the CC BY License. © 2019 Smith CT et al. JAMA Network Open.

See also 2.10.3, Acknowledgments [Article Information], Information on Open Access.

The year in the copyright notice should be the year of publication. Journal home pages and other main pages of journal websites should change the year of copyright notice at the beginning of each year, but back-issue content should retain the copyright year for the original year of publication.

According to the US Copyright Office, registration creates a public record of key facts that relate to the authorship and ownership of the claimed work, including the title of the work, the author of the work, the name and address of the claimant or copyright owner, the year of creation, and information about whether the work is published, has been previously registered, or includes preexisting material.⁶⁰ Registration is not required for copyright protection, and failure to register a work does not affect the copyright owner’s rights in that property. However, registration does offer several benefits: it establishes a public record of the copyright claim and is a prerequisite to bringing suit for copyright infringement in US courts.⁶⁰ Registration requires a completed application form, filing fee, and the deposition of copies of the work (usually 2 copies of printed materials or the submission of identifying material for electronic publications).^16(§408) Registration is best made within 3 months of publication.^60,73 Registration filing fees vary for single original works, serials (including journals, periodicals, newspapers, annuals, and proceedings), visual and performing arts, sound recordings, and copyright renewals and are available online from the US Copyright Office at http://www.copyright.gov.

5.6.7 Copying, Reproducing, Adapting, and Other Uses of Content.

To copy or reproduce an entire work without authorization from the copyright owner constitutes copyright infringement. However, a reasonable type and amount of copying of a copyrighted work is permitted under the fair use provisions of US copyright law.^16(§107)

5.6.7.1 Fair Use.

What constitutes fair use of copyrighted material in a given case depends on the following 4 factors^16(§107):

1.Purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes

2.Nature of the copyrighted work

3.Amount and substantiality of the portion used in relation to the copyrighted work as a whole

4.Effect of the use on the potential market for or value of the copyrighted work

Although each of these factors may provide a safe haven for use of copyrighted works without permission from the owner, the fourth factor, the market value of the original work, has been considered important by the courts in copyright infringement cases.

Fair use purposes include “criticism, comment, news reporting, teaching, scholarship, or research.”^16(§107) This allows authors to quote, copy, or reproduce small amounts of text or graphic material. Appropriate credit should always be given to the original source. In the case of a direct quote, quotation marks or setting off the quoted material, with an appropriate reference or footnote to the original source, is required (see 5.4.2, Misappropriation: Plagiarism and Breaches of Confidentiality).

5.6.7.2 Text.

The amount of text subject to fair use is determined by its proportion of the whole, but this proportion is not measurable by word count. Contrary to popular belief, there are no specific numbers of words or lines or amount of content that may be taken without permission. The so-called 300-word rule has been cited erroneously to justify quoting passages of text without permission. This erroneous assertion probably originated with the custom of sending out review copies of books and allowing reviewers to quote passages of 300 words or less in a published review. In 1985, The Nation magazine lost a landmark suit for copyright infringement after publishing a 300-word excerpt from former US President Gerald Ford’s 200 000-word unpublished memoir, which was to be published as a book by Harper & Row (Harper & Row Publishers, Inc v Nation Enterprises).⁷⁴ In this case, the trial court ruled that the excerpt “was essentially the heart of the book.”⁷⁴ The Chicago Manual of Style recommends that a quote never extend more than a “few contiguous paragraphs” and that quotes, even if interrupted by original text, should not “overshadow the quoter’s own material.”^73(§4.86) The length quoted should never be such that it would diminish the potential market for or value of the original work (see 5.3, Duplicate Publication and Submission, and 5.4.2, Misappropriation: Plagiarism and Breaches of Confidentiality).

5.6.7.3 Tables, Graphs, and Illustrations.

Fair use of tabular and graphic material and illustrations is more difficult to assess. Although 1 or 2 lines of information from a table might be used without permission, reprinting the entire table without permission is inappropriate and could result in a claim of copyright infringement. The same applies to graphs and illustrations. For example, the JAMA Network journals require all authors to obtain permission to adapt a major part of or republish an entire table, graph, or illustration that has been previously published (unless published under an unrestricted Creative Commons license). Unrestricted permission is needed to reproduce this material in all “print, online, and licensed versions” of the journal. Many publishers permit online users to download copies of tables, graphs, and illustrations as slides or other formats that include citation to the original work for use in teaching.

5.6.7.4 Photographs and Works of Art.

Photographs and works of art protected by copyright may not be reproduced, enhanced, or altered without permission of the copyright owner, who may be the photographer or artist, a museum or gallery, an academic institution, a commercial entity, or a previous publisher. For example, the JAMA Network journals obtain permission from owners of copyrights of works of art, typically museums and galleries, to reproduce these in humanities and other articles. In this case, the journal receives a nonexclusive 1-time right to reproduce the art in an article in print and online, which does not permit reuse of the artwork in other works without obtaining permission for such secondary use from the copyright owner of the work of art.

5.6.7.5 Unpublished Works.

Authors should not rely on the fair use provision to justify quoting from unpublished manuscripts and letters.^69,73 In several cases, the US courts have taken a conservative view toward use of extensive quotations and paraphrasing from unpublished works without permission, making it difficult to justify such use. For example, in J. D. Salinger v Random House, Inc,⁷⁵ the Second Court of Appeals ruled that inclusion of extensive quotes from Salinger’s unpublished letters in Hamilton’s unauthorized biography of Salinger was improper. In a subsequent case, New Era Publications International, ApS v Henry Holt and Company, Inc,⁷⁶ the trial court ruled that quotation from unpublished work was not fair use “even if necessary to document serious character defects of an important public figure.” For terms and conditions of copyright protection for unpublished works, see Table 5.6-1.

5.6.7.6 Correspondence and Reviews Regarding Manuscripts and the Editorial Process.

All correspondence regarding a manuscript and the editorial process is considered unpublished and confidential and thus should not be used without knowledge of the owner of the correspondence. In the case of a letter, the letter writer is the owner. In the case of a manuscript review, the peer reviewer is the owner, unless the reviewer was contracted under a work-for-hire provision. Thus, authors and journals have no legal right to publish extensive quotes or paraphrases of reviews without the reviewer’s consent (see 5.7.1, Confidentiality During Editorial Evaluation and Peer Review and After Publication) or of letters, not submitted for publication, without the letter writer’s permission (see 5.6.7.7, Copying, Reproducing, Adapting, and Other Uses of Content, Quotes and Paraphrases From Oral and Written Communications). In addition, to date, the courts have not allowed attempts to gain access to confidential peer review records or confidential information about manuscripts that are not published or not included in published articles (see 5.7.1, Confidentiality During Editorial Evaluation and Peer Review and After Publication).

5.6.7.7 Quotes and Paraphrases From Oral and Written Communications.

Many journals accept citations to personal communications (ie, oral and written communications). Court decisions regarding use of unpublished works^75,76 indicate that written communication, such as a letter or a memorandum (whether handwritten, typed, printed, or in digital format), if unpublished, may require permission from the letter or memo writer to be cited in a published work. Unless recorded, an oral communication, such as a personal or telephone conversation, cannot be copyrighted. However, authors should obtain written permission from the sources of quotations that are cited as oral and written communications in their manuscripts and should provide a copy of all such permissions to the journal³⁴ (see 3.13.10, Personal Communications).

5.6.7.8 Works in the Public Domain.

Works in the public domain (which are not protected by copyright) may be quoted freely, with proper credit given to the original source. Examples of works in the public domain include those funded completely by the US government and those works on which the copyright term has expired (see 5.6.4.6, Works in the Public Domain or Created by the US Government). Other examples are available from Project Gutenberg.⁷¹

5.6.7.9 Abstracts.

One widely debated application of fair use is the reproduction of abstracts of journal articles in other publications or databases. It can be argued that abstracts, especially structured abstracts, represent the whole work. As a result, any secondary publication or commercial use of abstracts of journal articles as derivative works in print or online without permission of the copyright owner may be considered copyright infringement.

5.6.7.10 Digital Images, Multimedia, and Other Works.

Fair use considerations apply equally to reproductions of copyrighted material published in digital format. That is, what is considered fair use in the print domain is likewise fair use in the electronic world. Copyright infringement is a violation of the law—whether the infringed work is photocopied, printed, or copied electronically (see also discussion of the US Digital Millennium Copyright Act in 5.6.3, Copyright: Definition, History, and Current Law). Thus, digital works (eg, digitally produced or reproduced photographs, slides, radiographs, scans, chromatographs, audio, and video) are protected under copyright law and require permission from the copyright owner to be reproduced in a publication.

With high-performance computer technology, digital images can be manipulated to enhance communication. However, digital adjustments could also be used to bias findings or to deceive. Journals should have guidelines for submission (including recommended file formats and sizes for editorial review and publication), enhancement, and publication of digital images, audio, and video that require authors to identify the software used as well as a record of how the original work was obtained and whether it was altered or manipulated.^77,78 Some journals have defined acceptable alterations (such as cropping) and proposed the use of standards for color, brightness, and scale. Others have developed mechanisms to identify inappropriate manipulation^77,78 (see 5.4.3, Inappropriate Manipulation of Digital Images, and 4.2.5, Photographs and Clinical Imaging).

5.6.7.11 Social Media.

Publishers, editors, and authors use social media to promote readership and encourage dialogue about articles and related content. Social media users should be aware of risks associated with unauthorized use, reuse, and sharing of content protected by copyright or trademark. Even if safe-harbor provisions protect online content providers, copyright infringement can occur, and users (publishers, editors, and authors) may be held liable for such infringement. Standard practices for obtaining rights or permissions to copyright-protected content apply in social media. Social media users should also be aware of user agreements of some commercial social media companies that claim ownership of all content posted and shared via these social media networks and sites.

5.6.7.12 Linking and Framing.

Linking is a fundamental feature of any electronic publication. Many online versions of articles contain hypertext links within the article (eg, to and from citations to references, tables, figures, supplemental content, and multimedia) and links external to the article (eg, to other articles or resources). Such linking is generally considered appropriate use. However, deep linking into a particular internal page of a website, especially if it permits circumvention of access restrictions or barriers, may be considered an unlawful use of the linked-to material.^61(p215) Framing is the enclosure and display of another’s content within a frame that has the branding and navigation of the framing site but without actually delivering the user to that site. Such framing may be argued to be the creation of a derivative work, which, if done without permission, will likely be regarded as an infringement.^61(p218)

5.6.7.13 Fair Use Exclusions and Reproduction Permission/Credit Language.

If a portion of a copyrighted work is to be used in a subsequent work and such use is not fair use, written permission must be obtained from the copyright owner (see 5.6.8, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Permissions for Reuse). Examples of such portions include text, tables, graphs, illustrations, or photographs. It is never permissible to use an entire article unless permission to do so is obtained in writing or the article is not protected by copyright. If there is doubt about the copyright status of a particular work, an inquiry should be directed to the author, publisher, or national copyright office. In all cases, the material should carry a proper credit line and, if applicable, copyright notice:

Data Adapted From Table and Used in Subsequent Article

Table 1 is adapted with permission from Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-810. doi:10.1001/jama.2016.0287. Copyright 2016 American Medical Association.

Republishing Entire Article

Republished with permission from JAMA. 2016;315(8):801-810. doi:10.1001/jama.2016.0287. Copyright 2016 American Medical Association.

Republishing Part of on an Entire Figure

Source: The left panel of Figure 2 was reproduced with permission from the American Society of Hematology.

Republished under the Creative Commons Attribution (CC-BY 4.0).

Note: Since most publications have an online presence or may do so in the future, it is not appropriate to use the wording “reprinted with permission.” All permission and credit lines should use words such as “reproduced” or “republished.”

5.6.8 Permissions for Reuse.

The copyright owner has the right to attach conditions to giving permission for reuse whether in print or electronic format, such as requiring proper credit and copyright notice. Permission is usually granted by most publishers without charge or with a small processing fee to use portions (text, figures, or tables) of articles or other works when such use will not result in commercial gain. To expedite review of permission requests, requestors should include the following information in each request:

■Title and complete citation of the original work

■Indication of the portion of the work to be reused, if not the entire work

■Information about the secondary use or publication in which the work will appear (including commercial or noncommercial use, method of dissemination, and intended audience)

■Scope of reuse rights (eg, nonexclusive, worldwide, all languages, print, online, and licensed versions)

Many journals/publishers may use an online service for processing or requests and permissions to reproduce content. Some journals may provide authors with instructions and a form for obtaining rights for reproducing or adapting material that is owned by others. See the sample form used by the JAMA Network journals in Box 5.6-1.

Box 5.6-1. Requirements for Reproducing or Adapting Copyright-Protected Material for Publication in JAMA: Guidelines for Authors

Permission to reproduce or adapt copyright-protected material (tables, figures, videos, or substantial portions of text) in JAMA must be obtained from the copyright owner.

In general, publishers hold the copyright to material previously published in journals, books, and digital media, but in some instances, especially for illustrations, photographs, and videos, the original creator of the work may retain copyright. Copyright to unpublished material is usually held by the creator of the work.

If you wish to include copyright-protected material in your article, please provide BOTH of the following items:

❏1. Written permission from the copyright owner of the material (see instructions that follow);

AND

❏2. For previously published material, a copy of the original publication (journal article, book chapter, etc) in which the content appeared.

How to Request Permission

For previously published material, direct your request for grant of permission to the permissions department of the journal or publisher. For unpublished material, contact the creator of the work to find out who owns the copyright. Request permission as soon as possible. In the event that your request cannot be granted, you will need time to substitute other material.

Include all of the following information in your request (see attached form):

1. Your Contact Information

Name, mailing address, telephone number, and email address.

2. Information About the Material to Be Used

Complete Source Citation

For Journals: Author(s), article title, journal title, year of publication, volume number, issue number, and inclusive page numbers.

For Books: Author(s) or editor(s), book title, publisher, year of copyright, and inclusive page numbers.

Material You Wish to Use

Specify by figure, table, or video number(s) or identify the portion of text.

3. How the Material Is to Be Used

Title of your article to be published in JAMA

Names of author(s)

4. Terms of Use

Use of the material in print, online, and licensed versions of JAMA

Nonexclusive rights

Unrestricted time

All languages

Note: We cannot accept permissions that restrict use to one-time only or to English-language only.

Include the permission(s) and copy(ies) of the original material with your manuscript.

Request for Permission to Reproduce or Adapt Copyright-Protected Material for Publication in JAMA

To:__________________________________  Date:_________________________________

Copyright Owner, Publisher, or Other

I (we) request permission to reproduce or adapt the material specified below in JAMA. Citation to the original publication or appropriate credit will be published. A grant of permission form is included for your use.

Requestor’s Contact Information

Name________________________________ Title__________________________________

Organization_________________________________________________________________

Mailing Address_______________________________________________________________

City____________ State/Province _________Zip/Postal Code_________ Country__________

Telephone_________________ Email___________________________

Source Citation of Material to Be Used (Please Print)

For Journals: Author(s), article title, journal, year of publication, volume number, issue number, and inclusive pages.

For Books: Author(s) or editor(s), book title, publisher, year of copyright and inclusive pages.

Description of Material: Specify figure, table, or video number(s) or description of text and page number(s).

How the Content Is to Be Used (Please Print)

JAMA Manuscript Number (if known)__________

Corresponding Author:_________________________________

Title of Article__________________________________________________________________

Terms of use: Use in print, online, and licensed versions of JAMA

 Nonexclusive rights

 Unrestricted time

 All languages

Note: We cannot accept permissions that restrict use to one-time only or to English-language only.

Grant of Permission: Please complete and return this to the requestor listed above.

I/we hold copyright to the material specified above and grant permission for its use in association with the designated JAMA article in print, online, and licensed versions of JAMA according to the terms listed above.

For previously published content, citation to the original publication will accompany the content.

For unpublished content, copyright credit should read as follows (please print):

Signature of Copyright Owner or Designate

Print Name of Copyright Owner or Designate

5.6.9 Standards for Commercial Reprints and e-Prints.

Pharmaceutical and device companies, institutions, and other organizations may purchase nonexclusive rights to reproduce scientific articles as reprints or provide access to these as e-prints, single articles, or collections of articles to help market their products. A reprint is the republication of an article or collection of articles in which the content is unchanged from the original publication (except perhaps for the inclusion of postpublication corrections). An e-print is a digital reproduction of or an online link to an article or collection of articles, usually PDF file(s) (see 5.12.7, Reprints and e-Prints). These sponsored materials often are produced and distributed by custom publishing companies and marketing agencies. To ensure the quality of these reprints and e-prints and to protect the integrity of the scientific journals that originally published the articles, the publishers and editors of the JAMA Network journals have developed standards for sponsored reprints and e-prints (Box 5.6-2).⁷⁹

Box 5.6-2. The JAMA Network Journals Standards for Reprints and e-Prints Purchased by Organizations

Fundamental Principles

The JAMA Network strives to produce medical research and information that adheres to the highest professional standards. The JAMA Network editorial process is designed to ensure that all published information is timely, rigorously peer-reviewed, and clinically relevant.

Reprints may not imply endorsement of a product or influence by an organization. Each reprint request is subject to approval by the JAMA Network, which reserves the right to reject orders deemed not in keeping with our standards.

Ownership of Copyright

Materials published in JAMA Network journals, including subsequent translations, are owned and copyrighted by the American Medical Association (AMA), unless there is indication of copyright owned by others or that the material is under a publication license. Materials under AMA copyright remain the property of the AMA and may not be reproduced in any form without written permission from the publisher. The AMA encourages reporting of any suspected unauthorized use to the AMA. The AMA is responsible for securing all necessary permissions.

Content

All JAMA Network editorial content must be reproduced verbatim for a reprint or e-print. Any reprints or e-prints of content that has been corrected should incorporate that correction either at the end of the article or as a notation. No content is available for reprints or e-prints prior to publication in a JAMA Network journal. Articles published online ahead of print may be purchased as e-prints or reprints on the date they are published online, provided they meet all the criteria listed above.

In the event that a correction is necessary for an article, reprints or e-prints of the article will be unavailable until the correction is published.

Single-Article Reprints in Paper Format

The policies outlined below apply to paper reprints of a single JAMA Network article or multiple related articles from a single issue as indicated by an editorial notation (eg, an Original Investigation that refers to a Commentary, Editorial, etc).

Policy and Procedures

1.Single-article reprints are subject to JAMA Network Fundamental Principles and approval.

2.With rare exceptions, reprints must include a front cover that includes the following:

✵Name/logo of journal

✵JAMA Network logo

✵Title of article, complete list of authors, and issue date

✵The phrase "Reprint Article" or its translation must appear at the top of the cover. No other content is permitted on the front cover.

3.Reprints must also include the original running footer plus the following information:

“(Reprinted) Journal Name” and copyright information.

4.Prescribing information or disclaimers required or approved by a government regulatory body (eg, US Food and Drug Administration [FDA]) or the purchasing company’s inventory numbers may be included subject to JAMA Network Fundamental Principles and approval. When prescribing information is required, the printed product will consist of the article followed by a buffer page and then the prescribing information. The buffer page will include a statement similar to the following:

“This reprint is provided courtesy of [company name], which has a financial interest in the product/topic discussed in this article. The following FDA-approved labeling has been provided by [company name]. [Journal Name] and the AMA do not assume responsibility for the content of the following information.”

Note: The above statement is permitted only on the buffer page for approved prescribing information.

5.Reprint holders and all materials contained therein (cover letters and other materials printed as part of, attached to, or surrounding a reprint) are subject to JAMA Network Fundamental Principles and approval.

6.No promotional material may be included with or attached to the reprint.

7.The following disclosure, or its translation, may be included in 8-pt type on the bottom of the noncontent back cover page.

“This reprint is provided courtesy of [company name], which has a financial interest in the product/topic discussed in this article.”

Web and Other Electronic Formats (Green Prints)

The policies outlined below apply to JAMA Network journals e-prints, which are currently available in 2 formats:

Access via a link to the PDF that resides on our dedicated provider e-print server for a specific number of accesses or length of time

A downloadable rights-protected PDF-based e-print

Policy and Procedures

Organizations may purchase JAMA Network journals e-prints under the conditions outlined in the Fundamental Principles section and under the following product-specific conditions:

1.e-Print requests, including the web page or email message that links to the article, are subject to JAMA Network Fundamental Principles and approval.

2.The requested e-print must adhere to the following criteria:

✵The content of the article PDF will not be altered.

✵The web page or email message must not describe or interpret the article.

✵The link to the article(s) must be separate from any marketing or other nonjournal content (ie, separate header stating “Journal Resources” or similar).

✵The link must include the full citation to the article (ie, author, title, and journal name, year, volume, issue, pages, or DOI if the article has been published online ahead of print).

✵The name of the company sponsoring the website or email message must be clearly displayed.

✵After JAMA Network approval, the link and the information surrounding the link must not be changed without prior approval.

3.Following approval, access will be granted to the electronic article.

Access to a PDF-Based e-Print Residing on the AMA e-Prints Dedicated Server

Purchasing organizations wishing to link to an AMA journal article PDF may purchase access to that PDF for a specific number of accesses or length of time, provided that the above stipulations are met. A URL link will be provided to enable the purchasing organization to establish password-free access from the supporting company’s linking page to the e-print PDF. The purchasing organization will maintain this link for the duration of the agreement.

Access to a Rights-Protected, Freestanding PDF-based e-Print

This e-print is a downloadable rights-protected PDF of the article(s) that is similar in appearance to a paper reprint.

Rights-protected PDF-based e-prints will include the cover page and running footer requirements described in the paper-format reprint section Single Article Reprint of these standards.

Prescribing information or disclaimers required or approved by a government regulatory body (eg, FDA) may be included with a PDF e-print subject to the JAMA Network Fundamental Principles and approval process. When prescribing information is included, a buffer page with disclaimer information (described in Single-Article Reprints, Paper Format, Item 4) will be required. Such information will be attached to the original article PDF and then locked (rights protected) prior to delivery.

The company website and specific page and/or email from which the rights-protected PDF e-print will link are subject to the JAMA Network Fundamental Principles and AMA eprint criteria.

An organization may purchase multiple e-prints on a related subject. These e-prints may be packaged together via links or bundled into a single rights-protected PDF. When these electronic packages consist of articles not related by editorial notation in the original publication, they will be subject to the JAMA Network Fundamental Principles and product-specific conditions approval process.

The JAMA Network Journals Reprint Collections

The policies outlined below apply to collections of articles drawn from a single issue or multiple issues of JAMA Network journals. These products may be in print or electronic format.

Policy and Procedures

1.JAMA Network Reprint Collections are subject to JAMA Network Fundamental Principles and approval. They must also meet the following product-specific conditions:

✵The customer selects a topic, core article, or selection of articles for a reprint collection and submits a request to the JAMA Network.

✵The JAMA Network proposal will include the selected articles, the proposed purchaser(s) and distribution mechanism(s), along with a PDF mock-up of the design for approval.

✵No promotional material for a product or activity involving the purchasing organization may be included with or attached to the Reprint Collection.

2.Prescribing information or disclaimers required or approved by a government regulatory body (eg, US Food and Drug Administration [FDA]) or the purchasing company’s inventory numbers may be included subject to the JAMA Network Fundamental Principles and approval. When prescribing information is required, the printed product will consist of the article followed by a buffer page and then the prescribing information. The buffer page will include a statement similar to the following:

“This reprint is provided courtesy of [company name], which has a financial interest in the product/topic discussed in this article. The following FDA-approved labeling has been provided by [company name]. [Journal Name] and the AMA do not assume responsibility for the content of the following information.”

Note: The above statement is permitted only on the buffer page for approved prescribing information.

3.Reprint holders and all materials contained therein (cover letters and other materials printed as part of, attached to, or surrounding a reprint) are subject to JAMA Network Fundamental Principles and approval.

5.6.10 Standards for Licensed International Editions.

A publisher may license others to publish international or translated editions of its scientific journals. To ensure the quality of these editions, the following standards are recommended:

■Copyright in the international edition and all translated articles is owned by the original publisher, unless articles or parts of articles are governed by a specific publication license (in which case such should be indicated on or within each specific article).

■Each issue must contain a minimum number of pages or amount of content.

■Articles republished from the original journal must account for a minimum of 50% of each issue’s total pages or content. The remaining 50% of total pages or content may include local editorial material and local commercial content (eg, advertisements).

■The licensed publisher will appoint an editorial director (whose appointment will be approved by the editor of the original journal) to select articles from the original edition to be republished in the international edition and review the quality of translations.

■Each republished article must include a complete citation to the original article (ie, journal, year, volume and issue numbers, inclusive page numbers or e-locator, and DOI) and complete original titles, author bylines, and author affiliations.

■Abridgments or changes to original content, other than translation, are not permitted.

■Content should be republished within a minimum amount of time (eg, 6 months from date of original publication).

■International editions may include local editorial material that cannot constitute more than 50% of total pages or content. Local editorial includes the cover (if the original journal cover is not used), masthead, table of contents, editorial indexes, brief news reports, summaries of conferences, meeting calendars, announcements, commentaries, editorials, letters, and explanations of original articles.

■Local editorial does not include (1) any original clinical or scientific articles (ie, quantitative or qualitative research reports or analyses, case descriptions, clinical or product reviews, product or therapeutic comparisons, scientific abstracts) or (2) any articles previously published by other journals.

■All authors of all local editorial should have their complete names, academic degrees or credentials, and affiliations published with each article.

■For online publications, translated articles should link to the original article.

■Journals with advertising should have multiple advertisements and should not be sponsored by one commercial entity or interest.

■Advertisements in print editions should not appear adjacent to editorial content on the same topic; advertisements in online editions should follow the same policies for online advertising as the parent edition.

■Commercial content shall not be presented to appear as editorial content. Appearance, artwork, and format shall be of such a nature as to avoid confusion with the editorial content of the publication.

See 5.12, Advertisements, Advertorials, Sponsorship, Supplements, Reprints, and e-Prints.

5.6.11 International Copyright Protection.

There is no international copyright law.⁶⁷ Copyright law, scope, protections, and remedies are governed by individual nations and treaties among them. Thus, copyright laws do not automatically protect an author’s work throughout the world. However, most countries offer protection to works from other nations.^67,80 For a detailed discussion of the copyright laws of individual countries, consult the World Intellectual Property Organization (WIPO), which is under the auspices of the United Nations in Geneva, Switzerland.⁸⁰ See 5.6.13, Copyright Resources, for contact information for WIPO.

The Berne Convention for the Protection of Literary and Artistic Works (commonly known as the Berne Convention)⁸¹ was originally signed by 10 European countries in 1886 in Berne, Switzerland, to protect copyright across their national borders.^67,81 Today, the Berne Convention is administered by WIPO. For many years, the United States declined to sign on to the Berne Convention because of its lack of formality and its minimalist approach. For example, the Berne Convention does not require the use of a copyright notice, which was in conflict with prior US copyright law. To accommodate the US need for a minimum set of standards, the Universal Copyright Convention (UCC) was created by the United Nations Educational, Scientific, and Cultural Organization (UNESCO) in 1952. Under the UCC, works created in the United States could have multilateral protection without forfeiting the prior US requirement for copyright notice.⁶⁶

After amending its copyright law by eliminating the requirement for copyright notice, the United States signed the Berne Convention in 1989. Most resource-rich nations and many transitional countries subscribe to this convention, and there are special provisions for resource-limited countries that wish to make use of them.⁸¹ As of 2019, 176 nations had signed on to the Berne Convention.⁸¹ The Berne Convention has no formal requirements. However, each signatory country agrees to protect the copyright in works created in other member countries. Although the United States no longer mandates the use of copyright notice, the US Copyright Office still encourages voluntary use (see 5.6.6, Copyright Notice and Registration). The significance of the UCC is now largely historical after the adoption of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and other international agreements in the 1990s, including WIPO’s Copyright and Performances and Phonograms Treaty and the WIPO Copyright Treaty. The WIPO Copyright Treaties, adopted in 1996, provide additional protections for works created in other member countries and address issues and questions raised by new economic, social, cultural, and technological developments as well as new international rules.

5.6.12 Moral Rights.

Moral rights, first introduced by the French as droit moral, is a doctrine of copyright law intended to protect individual creators’ noneconomic investments in their work and the personality of the creator as it relates to the work regardless of copyright ownership or transfer.^{62(§25.03),81} Two moral rights that are most often recognized are the right to attribution and the right to integrity (ie, right to prevent destruction or mutilation of work).^62(§25.03) This doctrine is endorsed by most member countries of the Berne Convention. Although the United States is a member of the Berne Convention, US law does not provide for moral rights, except for certain visual works of art to protect them from mutilation or misattribution through the Visual Artists Rights Act of 1990.^16(§106A) Creators of other works in the United States are provided limited moral rights protection under other federal laws (such as the Lanham Act), state laws, or contracts that include specific provisions for moral rights.^62(§25.03) Under interpretations of relevant US laws as well as any applicable contract provisions, US editors and publishers may not give authorship credit to someone who has not written the work and may not credit an author of a written work without the author’s permission (see 5.1.2, Guest and Ghost Authors and Other Contributors). In the United States, courts have also held that mutilation of a work (distortion or substantial alteration of the work without consent of the author) may result in copyright infringement.^62(§25) However, authors are not similarly protected against unauthorized changes made during editing and publication of their work.^62(§25) Because of the ease of manipulation and distortion of electronic works, concerns about moral rights in the context of electronic publishing are increasing in the United States and may portend changes in this area of law in the future.^62(§25)

5.6.13 Copyright Resources.

Additional information about copyright law may be obtained from several sources. For a detailed legal account, consult Perle and Williams on Publishing Law ⁶² or Nimmer on Copyright ⁶⁴ (although these resources are expensive and may be best consulted via a library that has these in its holdings). Other useful texts include the Chicago Manual of Style chapter “Rights, Permissions, and Copyright Administration”⁷³ and Internet Law: A Field Guide.⁶¹ Specific information, useful guides, and forms may be obtained free of charge from the US Copyright Office.^{16,60,63,66,67,69}

US Copyright Office

Library of Congress

101 Independence Ave SE

Washington, DC 20559-6000

Telephone: 202-707-3000 or 877-476-0778

www.copyright.gov

Additional useful information can also be obtained from the following:

Association of American Publishers (AAP)

455 Massachusetts Ave NW, Ste 700

Washington, DC 20001

Telephone: 202-347-3375

www.publishers.org

Association of Learned and Professional Society Publishers (ALPSP)

Egale 1, 80 St Albans Rd

Watford, Hertfordshire

WD17 1DL UK

Telephone: +44-1245-260571

Email: admin@alpsp.org

www.alpsp.org/default.htm

STM: International Association of Scientific, Technical and Medical Publishers

Prama House

267 Banbury Rd

Oxford

OX2 7HT UK

Telephone: +44-1865-339-321

https://www.stm-assoc.org/

World Intellectual Property Organization (WIPO)

34, chemin des Colombettes

CH-1211 Geneva 20, Switzerland

Telephone: 41 22 338 9111

http://www.wipo.int/portal/en/

5.6.14 Patents.

Patents protect different types of intellectual property than do copyright and trademark. Patent law protects invention and technology, copyright protects an original artistic or literary work (see 5.6.1, Ownership and Control of Data), and trademark protects brand names and logos used on goods and services (see 5.6.15, Trademark).

A patent is a grant of property right by the government to protect a newly created idea on the basis of its technical and legal merit.⁸² In biomedicine, patents are commonly applied for and approved for new products, such as pharmaceuticals, reagents, assays, devices, equipment, procedures, and methods. Patent law is intended to encourage discovery and investment in research of new technology by rewarding an inventor with a monopoly on the right to market the new product for a specified period. This law restricts other parties from manufacturing, selling, or using the new product without the patent holder’s permission, generally for a period of 20 years.⁸²

The US Patent and Trademark Office (USPTO) defines 3 types of patents for invention and discoveries⁸²:

Utility patents: for a new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof.

Design patents: for a new, original, and ornamental design for an article of manufacture.

Plant patents: for the asexual reproduction of any distinct and new variety of plant.

In the United States, patents are awarded by the USPTO. For more details, instructions, and copies of patent forms, contact the USPTO:

US Patent and Trademark Office

Department of Commerce

Washington, DC 20231

Telephone: (571) 272-1000 or (800) 786-9199

Email: usptoinfo@uspto.gov

https://www.uspto.gov/

As with copyright, there is no international patent law or protection; patents are protected by individual countries. In some regions, a regional patent office (eg, the European Patent Office or the African Regional Intellectual Property Organization) accepts and grants patent applications in the member states of that region. Several international treaties (eg, the Paris Convention for the Protection of Industrial Property and the Patent Cooperation Treaty) support cross-country rights in patent and trademark matters.⁸² Detailed information about international treaties on patents is available from WIPO (for contact information, see 5.6.13, Copyright Resources).

Controversies continue over claims for patents of naturally occurring substances, medical and surgical methods, and even genetically altered cells, gene fragments, and genetically based diagnostic tests.^{83,84,85,86,87} Desires for profit and primacy of discovery have caused delay or suppression of the publication of important medical information.^12,13,88 In 2014, the US Supreme Court ruled in favor of the Association for Molecular Pathology (v Myriad Genetics, Inc) and declared that isolated human genes cannot be patented.⁸⁹ However, related ethical issues and concerns about experimental reproducibility for such patent claims persist.^82,87,88,89 For these reasons, editors should request that authors disclose information about patents, including ownership and upcoming and pending applications for patent grants, that are related to the work included in their submitted manuscripts in their financial disclosures to journals (see 5.5, Conflicts of Interest).

5.6.15 Trademark.

Trademark and unfair-competition laws are designed to prevent a competitor from selling goods or services under the auspices of another. Trademark law, not copyright law, protects trademarks, service marks, and trade names.⁹⁰ Trademarks are legally registered words, names, symbols, designs, or any combination of these items that are used to identify and distinguish goods from those goods manufactured and sold by others and to indicate the source or origin of the goods (eg, brand names).⁹⁰ Examples of commonly recognized trademarks include the Wall Street Journal, NBC, and Coca-Cola. A service mark is the same as a trademark except that it is used to distinguish services, not goods, of a specific provider.⁹⁰ Examples of service marks include McDonald’s (restaurant services), AT&T (telecommunications services), and Amazon.com (online retail services). The terms trademark and mark are often used to refer to both trademarks and service marks,⁹⁰ and some companies use both (eg, Google). Trade names are the names given by manufacturers or businesses to specific products or services. For example, Synthroid is the trade name (or proprietary name) for the drug levothyroxine (see 14.4.3, Proprietary Names). Trade names are not legally protected in the same manner as are trademarks. Trademark law provides legal protection for titles, logos, fictional characters, pseudonyms, and unique groupings of words, symbols, or graphics.^62,90 Whereas copyright law protects an authored work, trademark law protects the words and symbols used in the marketing of that work.

Trademarks are classified into 4 categories in order of their increasing distinctiveness: generic, descriptive, suggestive, and fanciful or arbitrary.⁶² Suggestive and fanciful or arbitrary marks are more likely to receive trademark protection than are generic or descriptive marks.⁶² An example of an arbitrary mark (a common word that has no specific connection to its product) is Apple (the technology company); an example of a fanciful mark (created solely for use as a trademark) is Xerox. An example of a suggestive mark is Microsoft (suggestive of software for microcomputers). To receive trademark status, a mark must be distinctive (ie, not similar to other marks) and not generic or merely descriptive of a category of products. For example, trademark status was not awarded to World Book or Farmers’ Almanac because both were considered “merely descriptive of the contents of each publication,”⁹¹ and Software News magazine was not considered protectable because it referred to a class of products of which the magazine is a member (ie, it was generic).⁹¹ For additional information, contact the USPTO (contact information available in 5.6.14, Patents).

5.6.15.1 Titles.

Book titles are rarely protected under trademark law because of judicial reluctance to protect titles that are used only once.^62(§24.03) A few exceptions to this norm have occurred with book titles that have engendered common secondary meanings, that is, become widely recognized and associated with the name of the author or publisher (eg, Gone With the Wind).⁹¹ The title of a series of creative works (eg, book series, journals, magazines, newspapers, television series, or software) may more easily receive trademark protection than can the title of a single creative work.^{62(§24.03),91} Thus, JAMA is a trademarked title. In the biomedical sciences, it may be difficult to trademark journal titles that are generic and may not be distinguishable from the science or field the journal serves, such as the journals AIDS, Brain, or Stroke. However, some seemingly generic titles have been trademarked, such as Neurology and Pediatrics.

5.6.15.2 Logos.

Logos, designs, or symbols may also receive trademark protection if they distinguish particular goods or services and identify the source of those goods and services.^62(§24.05) Examples of such logos include the Bantam publishing house rooster and Apple computer’s apple. A background design, apart from the words imposed on it, can be protected by trademark if it is of a distinctive quality and functions to identify the source of a good.^62(§24.05)

5.6.15.3 Fictional Characters and Pseudonyms.

Fictional characters may be protected by trademark if they achieve secondary meaning and are widely recognized (eg, Mickey Mouse). Similarly, a pseudonym can be given trademark status.^62(§24.06)

5.6.15.4 Trade Dress.

Trade dress is the visual or physical appearance of a product or its packaging, which, if distinct from that of other similar products, may be protected under trademark law. Trade dress is intended to prevent marketplace confusions and to protect consumers from packaging or appearance of products that are designed to imitate other products and prevent consumers from purchasing one product under the belief that it is another. For example, the Coca Cola bottle, the label on Campbell’s soup, and the colors and shapes of certain pill capsules have qualified as protectable trade dress. Trade dress includes graphic elements and design, typography, shape, and color. For example, the designs, including the borders, of the print covers of the National Geographic and Time magazine have been awarded trademark status.^{62(§24.03),91} Historically, trade dress protection has generally applied to goods; however, trade dress protection has been extended to cover the overall “look and feel” of a website.⁹² The look and feel of a website may include elements such as borders, frames, colors, highlights, orientation, fonts, layout, images and graphics, animation, and sounds, as well as the arrangement and display of these elements. Thus, although the content of a website is likely protected under copyright law, the user interface might be protectable under trade dress application of trademark law. Some predatory or deceptive publishers have misused the likeness of well-known journals to hijack the journals and confuse prospective authors and entice them to submit to predatory or phony journals.⁹³ A test to determine whether the look and feel of a website has been infringed should include the following factors⁹²:

1.Overall similarity

✵Fonts and formatting

✵Color scheme

✵Sounds, animations, and visual effects

✵Symbols, logos, and marks

✵Layout and arrangement

✵User experience design

2.Proximity of products or services in the relevant market(s)

3.Intentional copying

4.Likelihood of consumer confusion

5.6.15.5 Application and Registration for Trademark Protection.

In the United States, application for a trademark registration can be made under both federal and state laws. A legal expert should be consulted for information about registering trademarks in other countries. However, registering a trademark is not sufficient; actual use of the trademark in a given market ensures protection (ie, the longer the actual use of the trademark, the stronger the legal protection).^62,91 Typically, the rights to a trademark belong to the first user in a specific geographic market.

Trademark protection is also governed by the national laws of individual countries and international treaties, such as the TRIPS agreement. In the United States, an application to register a trademark must be filed with the USPTO.⁹⁰ Applying for trademark protection is more complicated than applying for copyright protection. The USPTO requires a formal application to be submitted (preferably electronically), along with a drawing of the mark, samples of the mark as it has been used, and a filing fee.⁹⁰ The USPTO conducts a formal review of the application, which may take several months. The office may deny the request for registration if the mark is judged to be generic, merely descriptive, or similar to another registered mark (or a mark for which another application is under review). Registration may also be denied if the mark is not used or intended for use in interstate or international commerce. If the application is approved internally by the USPTO, a notice is published in the Official Gazette to make the application publicly known. During the 30 days after the Official Gazette notice, any third party can file a formal opposition to the application.⁹⁰

If the application is approved, the USPTO will issue a certificate of registration if the mark is in use. If the mark is not yet in use, the applicant is required to file a statement that describes the mark’s intended use and has 6 months to use the mark in commerce and submit a statement of such use or request a 6-month extension to file a statement of use.⁹⁰

5.6.15.6 Trademark Symbols.

Once registered, the mark is entitled to carry the trademark symbol ®. Only those marks that are officially registered by the USPTO can use the official symbol ®. Marks that are under review may use the symbol TM or SM, but these do not have legal significance.⁹⁰

5.6.15.7 Duration of Trademark Protection.

A US trademark registration extends for 10 years and may be extended indefinitely provided the owner continues to use the mark on or in connection with the applicable goods and/or services and files all required documentation with the USPTO at the appropriate times. For example, between the fifth and sixth years of the initial term and in the ninth year of every 10-year period thereafter, additional forms must be filed with the USPTO to ensure legal protection.⁹⁰

5.6.15.8 Loss of Trademark Rights and Antidilution Law

A mark can lose its legal protection if the owner discontinues using it (termed trademark abandonment), if the owner does not file a statement that the trademark is still in use between the fifth and sixth years of the initial term, or if the owner does not renew the registration by the end of each 10-year registration period.⁹⁰ Trademark protection may also be forfeited if a mark becomes too generic or no longer identifies goods or services with a particular source (ie, the mark becomes “diluted”). In legal terms, trademark dilution is the reduction of the capacity of a famous mark to identify and distinguish goods and services and occurs when a mark similar or identical to a famous mark reduces the value or distinctiveness of the famous mark to identify and distinguish its goods and services.^90,94 For example, Webster’s is no longer a registered trademark because the name lost its ability to identify a specific publisher of dictionaries, and Zipper is no longer a registered trademark for “slide fastener.”

A mark used in multiple contexts by different product owners or service providers may diminish the ability of a given mark to serve as unique identifier of that product or service.^62(§24),90 Such dilution of unique trademark status is known as blurring. A trademark may also be diluted by tarnishment, when a well-known trademark is improperly associated with an inferior or offensive product or service.^62(§24) The following factors may be considered in judging such dilution of unique trademark status of one mark by another ^62(§24.03):

■Similarity of marks

■Similarity of the products covered by the marks

■Sophistication of consumers

■Predatory intent

■Renown of the senior mark

■Renown of the junior mark

For this reason, owners of trademarks will often send letters to editors and publishers objecting to misuse of their trademarks in publication. Such demands are intended to keep trademarks from being diluted by common use. For example, authors and editors should not use trademark names as generic verbs, nouns, or modifiers (eg, use “photocopied” rather than “xeroxed”).

5.6.15.9 Use of Trademarked Names in Publication.

Under the US Federal Trademark Dilution Act,⁹⁴ restricted use of trademark names applies mainly to commercial use of trademarks, not to editorial use in publication. For example, a photography magazine may not use the word “Kodak®” as part of its cover design, and a computer manufacturer may not place the word “Kodak®” on the front of a computer. However, an author or editor may include the word “Kodak”—without the trademark symbol—in an article about cameras and film development without risking trademark infringement.

The symbol ®, or the letters TM or SM, should not be used in scientific journal articles or references, but the initial letter of a trademarked word should be capitalized (see 10.3.5, Proprietary Names).

On occasion, a trademark owner will request that its trademark or trade name appear in all capital letters or a combination of capital and lowercase letters, often with the trademark symbol. Authors and editors are not required by law to follow such requests. It is preferable to use an initial capital letter followed by all lowercase letters (eg, Xerox, Kodak, Scopus, Embase) unless the trademark name is an abbreviation (eg, IBM, JAMA, DSM-5) or uses an intercapped construction (eg, PubMed, iTunes) (see 10.9, “Intercapped” Compounds; 13.0, Abbreviations; and 14.4.3, Proprietary Names). Online databases, if trademarked, can be listed in all capital letters (eg, MEDLINE, CINAHL, SCIE).

5.6.15.10 International Trademark Protection.

Like copyright law, there is no international trademark law, and trademark protections are offered by different jurisdictions in different countries. However, WIPO (www.wipo.org)⁸⁰ administers the Madrid System for the International Registration of Marks, which offers a route to trademark protection in multiple countries by filing a single application. Information is also available from the International Trademark Association (www.inta.org).

5.6.15.11 Trademark Protection for Domain Names.

Domain names are internet addresses that point to a specific website, usually a home page. They are usually easily remembered names that are linked to numeric internet protocol (IP) addresses via a domain name system (DNS). Examples include uspto.gov or harvard.edu.^62(§25.09) Domain names include top-level domain (TLD) names (eg, “.com,” “.org,” “.edu”) and second-level names (eg, “jama” in jama.com or “nih” in nih.gov). A domain name is not automatically entitled to protection once registered; like other trademarks, it must be used in connection with the website located at that address.⁶¹

Since 1998, the Internet Corporation for Assigned Names and Numbers (ICANN) has been responsible for managing the domain name system.⁹⁵ Domain names can be registered by many different companies (known as registrars) that are authorized by ICANN. Domain name registrars have different terms for renewal of domain name registration, ranging from 1- to 10-year increments.⁹⁵ ICANN registrars manage many generic TLD (gTLD) names. Anyone can register for the following gTLDs: .com, .info, .net, .org. Some gTLDs are restricted to individuals or entities that belong to a defined community, such as .aero, .asia, .cat, .coop, .edu, .gov, .mil, .mobi, .museum, .tel, and .travel. ICANN does not accredit registrars for TLDs that are restricted to specific entities and purposes, such as “.edu” for educational institutions, “.gov” for US government agencies, and “.mil” for US military sites. In addition, there are hundreds of 2-letter country code TLDs that may be obtained from host country agencies in accordance with rules determined by the Internet Assigned Numbers Authority.⁹⁶

Disputes over ownership and rights to use domain names are considered under the principles of trademark infringement and dilution, with some specific additions to address cybersquatting and typosquatting.^61,62 Cybersquatting (or domain squatting) is the act of obtaining a trademark-associated domain name with the aim of benefitting from the association or selling it to the trademark owner ^61,95 Typosquatting is “the registration of a domain name that is similar to another’s for the purpose of capitalizing on typos that may lead the user to the squatter’s website rather than the site the user intends to locate.”^61,95 In 1999, the Anticybersquatting Consumer Protection Act was enacted to address these problems of misuse of domain names.^61,95

To make a successful claim against use of a specific domain name, the following must be demonstrated⁹⁵:

■the domain name is identical or confusingly similar to a trademark or service mark in which the complainant has rights,

■the registrant has no rights or legitimate interests in respect to the domain name, and

■the domain name has been registered and is being used in bad faith.

For more information on applying for and managing domain names and remedies for misuse of domain names, consult ICANN or WIPO (contact information for WIPO is available in 5.6.13, Ethical and Legal Considerations, Intellectual Property: Ownership, Access, Rights, and Management, Copyright Resources).

Internet Corporation for Assigned Names and Numbers (ICANN)

12025 Waterfront Dr, Ste 300

Los Angeles, CA 90094-2536

Telephone: (310) 301-5800

https://www.icann.org/

Contact information for international regional offices is also available in the Contact Us page of the ICANN website.

Principal Author: Annette Flanagin, RN, MA

Acknowledgment

I thank the following for review and helpful comments: Howard Bauchner, MD, JAMA and JAMA Network; Michael Clarke, Clarke & Esposito, Washington, DC; Timothy Gray, PhD, JAMA Network; Iris Y. Lo, JAMA Network; Joseph P. Thornton, JD, JAMA Network and American Medical Association; Elizabeth Wager, PhD, Sideview, Princes Risborough, UK; and Sara Zimmerman, JAMA Network.

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