On behalf of several leading non-profit professional biomedical associations, litigation partners David T. Ralston, Jr. and Philip A. Nacke have prepared what has emerged as the principal legal opposition to a new policy of the National Institutes of Health (NIH) concerning "enhanced access" to peer-reviewed articles about NIH-funded research. The new NIH policy, which has stirred a major debate in Washington, is designed to position NIH as an electronic publisher of all articles written by NIH-funded researchers concerning their funded research. As a publisher, NIH will compete directly with the professional, peer-reviewed biomedical journals published by non-profit biomedical associations. Moreover, NIH will rely on taxpayer subsidies to support its publishing operations so that NIH can publish the articles for the public at no-charge to the public users. The impact will be to severely undercut the non-profit publishers, who rely heavily on journal subscription revenues and advertising to support their publications, the peer-review process and their professional activities.
When a researcher receives a grant to conduct NIH-sponsored research, the researcher receives complete copyright ownership to all published materials prepared by the researcher on the results of the research. NIH retains a federal purpose license which allows it to obtain a copy of a published article prepared by the researcher concerning the funded research, archive the copy of the article and make the copy available to authorized federal government users. Typically, researchers submit their draft manuscripts to a professional journal for peer-review and consideration for publication. In exchange for the journal providing peer review and publishing the article, the researcher-author conveys copyright ownership of the article to the journal, subject to NIH.s right to obtain and use a copy of the article within the parameters of the federal purpose license.
Ralston and Nacke argue that the NIH policy is flawed because the plan:
- Would infringe on the copyright interests of (a) federal grantees or "Pis" of federal grantees who author copyrighted articles based upon NIH-sponsored research, and (b) publishers of professional journals that have accepted those articles for publication and to whom copyright interests have been conveyed.
- Fails to recognize the need to obtain copyright permission from authors and/or publishers to distribute or display manuscript copies to the public.
- Threatens to undercut the Bayh-Dole Act (concerning government grantees patent rights) by interfering with certain technology transfer.
- Constitutes a legislative rule under the Administrative Procedure Act, and NIH lacks the necessary rule-making authority to pursue such an initiative, but even if the authority were present, NIH has not undertaken the required rule-making procedures.
- Is subject to the Regulatory Flexibility Act, and NIH has not undertaken the required regulatory flexibility analyses.
- Is subject to the Paperwork Reduction Act, and NIH has not obtained the required approval from the Office of Management and Budget (OMB).
- Is subject to OMB Circular A-76 (requiring cost comparison studies before government agencies compete with the private sector), and NIH has not undertaken the required cost comparison studies.
- Would interfere with constitutionally protected property rights, and NIH has not satisfied the analytical and reporting requirements imposed by Executive Order upon proposed agency activities that, if implemented, could trigger the just compensation obligation of the Fifth Amendment.
They also observe that NIH's plan could inadvertently wreak havoc with researcher's patent right. The draft manuscripts required by NIH's policy to be submitted to NIH likely constitute "printed publications" under U.S. patent laws, triggering the one-year time period for filing a patent application in the United States, and possible altogether vitiating patent rights in some foreign countries.
The comments, prepared on behalf of Foley & Lardner clients The American Association of Immunologists and The American Physiological Society, can be accessed by clicking on the following links:
http://www.the-aps.org/news/nihaccesscomments.htm (click on .available here. at the bottom of page, Foley comments are pages 12-58 of the PDF file) and
http://www.aai.org/News_Board/CommentsNIHPublicAccess.pdf (pages 11-55).
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