June 1, 2005 (Vol. 25, No. 11)

Importance of Sharing Results of Government-funded Research

The increased public access policy to be effected by the National Institutes of Health (NIH) was originally conceived to change the way patent practioners interact with inventors of biologically or chemically based inventions. After receiving public comments on the proposed policy, the NIH has finalized the text of the policy to be effected May 2, 2005.

The final text of the policy greatly reduces concerns and legal issues that arose in the original text, but patent practitioners must still remain vigilant and in strong communication with their clients to maintain confidentiality of their disclosures until appropriate applications are filed.

Inventors of biologically or chemically based inventions are routinely encouraged to seek government funding, file for patent protection, and publish their discoveries in scientific journals. Careful coordination between the inventor and their patent attorney or agent is essential to ensure that the invention is not disclosed in a publicly available document before a patent application is filed.

The NIH policy is designed to increase public accessibility to NIH-funded research information. In accordance with the policy, researchers are now requested to post all final version manuscripts for NIH-funded research in a digital repository for biomedical research called PubMed Central.

This policy is intended to help disseminate NIH-funded research more quickly and efficiently to the public. The NIH has established a web page on this policy at www.nih.gov/about/publicaccess/index.htm that includes a summary of the comments submitted in response to the original text of the policy.

Purpose of the Policy

The House Appropriations Committee issued a report in July 2004 expressing concerns that insufficient public access exists to the reports and data resulting from NIH-funded research and that the public should have open access to information that has been derived from tax dollars.

In response to the July report, the NIH published an announcement in the NIH Guide for Grants and Contracts on September 3, 2004 (Notice: NOT-OD-04-064), and in the Federal Register on September 17, 2004 (Vol 69(180), page 56074), proposing changes to their procedures to grant public access to health-related research information upon publication of any research sponsored in whole or in part by the NIH.

According to the NIH, the purpose of the public access policy is to share the results of government-funded research in order to promote dissemination of new scientific information to other scientists, healthcare providers, students, teachers, and other Americans seeking credible medical information.

The NIH also indicated that the old system failed to provide a comprehensive archive of NIH-sponsored research publications needed to efficiently manage the NIH research portfolio, permanently preserve these published findings, and establish productivity of the agency to Congress.

The original text of the policy required researchers funded by the NIH to submit copies of all final-version manuscripts of documents relating to NIH-research, including research grants, cooperative agreements, contracts, as well as National Research Service Award fellowships, and contained provisions granting immediate access on PubMed Central for documents where the publication costs are paid for wholly or in part by the NIH.

Final Text of the New Policy

The proposed rulemaking originally prompted widespread comment from the publishing industry as well as legal professionals.

The new policy now requests that, upon acceptance for publication, NIH-supported investigators voluntarily provide the NIH with electronic copies of final versions of manuscripts relating to research that was supported in whole or in part by NIH funding. Final version manuscripts are defined as scientific articles accepted for journal publication including all modifications made during the peer-review process.

The final text of the policy has also been restricted to only peer-reviewed articles and does not apply to other publications such as book chapters, editorials, reviews, or conference proceedings. The most significant change in the policy from the first draft is that it now provides more flexibility for the researchers to specify the timing of the posting of their final manuscript for public accessibility through PubMed Central at the time of submission.

If the publisher agrees, public access to the publishers final version can occur sooner than the time originally specified by the author. Within 12 months after acceptance for publication of an NIH-funded project, documents will be made available freely to the public by posting on PubMed Central.

Practical Implications

The initial response to this report was widespread criticism from the scientific publishing industry which expected the policy to damage journal subscription revenues. However, aside from lost publishing revenues, there are also significant legal concerns that arose from the proposed policy regarding disclosure and the effect on patentability of an invention.

Fortunately, the final text has been revised to alleviate many legal concerns but the patent practitioner should be aware of the new policy to adequately counsel clients and ensure that proper filings occur prior to submission of manuscripts to the NIH.

Since any printed publication that precedes the filing date of an application can be used as prior art when determining novelty of an invention, published NIH documents could jeopardize U.S. patent rights if patent applications are not timely filed and could entirely destroy patent rights in many foreign countries.

The NIH does not believe that submission to PubMed Central under the Public Access Policy will constitute a printed publication. While the document would be indexed and catalogued, the publication itself would not be available to the public and therefore would not be considered available as a printed publication under 35 USC 102 and 103.

Patent practitioners and their clients will need to ensure that proper measures are taken to protect intellectual property rights before posting by the NIH of any federally funded research documents by the inventors.

University researchers and personnel at technology transfer offices should be aware that publications may be released sooner than anticipated in some instances. Therefore, for NIH-funded projects, it is imperative to ensure that patentable subject matter disclosed in research documents is adequately protected prior to acceptance of manuscripts.

Clients need to be instructed not to post final-version manuscripts on PubMed Central before publication by the journal. Officers at technology transfer offices may wish to closely monitor the acceptance of research articles for publication and educate scientists about this new proposal so that patent applications can be timely filed and ensure adequate protection of intellectual property.

Previous articlePreparation of Clinical Trials Materials
Next articleNematode Net