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NHGRI Policy Regarding Intellectual Property of Human Genomic Sequence

Policy on Availability and Patenting of Human Genomic DNA Sequence Produced by NHGRI Pilot Projects (Funded Under RFA HG-95-005)

April 9, 1996

This document describes the policy of the National Human Genome Research Institute (NHGRI) with respect to availability and patenting of human genomic DNA sequence produced under grants funded as a result of RFA HG-95-005. In conformity with the existing spirit and philosophy of the Human Genome Project (HGP) and in response to the recommendations of advisors and the expressed wishes of the community, NHGRI seeks to make DNA sequence information available as rapidly and freely as possible.

Background

The HGP is an international research effort, begun in 1990, which has the scientific goals of generating maps of the human genome [1] and producing the complete sequence of the human DNA by the year 2005. The project was undertaken in the U.S. following the advice of several scientific committees that emphasized its importance in creating a resource that "will facilitate research in biochemistry, physiology and medicine"[2], "have a major impact on health care and disease prevention" [2] and provide "enormous scientific and technological advances ... having both basic and commercial applications" [3]. At the National Institutes of Health (NIH), the National Human Genome Research Institute (NHGRI) was founded to implement the HGP.

The HGP has progressed rapidly, even beyond optimistic expectations. The initial mapping goals are nearly completed and recent improvements in DNA sequencing technology and capacity have led many scientists, including NHGRI advisors, to conclude that complete sequencing of human genomic DNA should begin. Early in 1995, NHGRI issued RFA HG-95-005 to solicit grant applications for pilot projects to test strategies that can potentially scale up to sequence the human genome. The applications received in response to the RFA were peer reviewed in the fall of 1995 and approved by the National Advisory Council for Human Genome Research (NACHGR) in January 1996. A set of grants will be funded by April 1996.

At the inception of the HGP, the planners emphasized that, in order to reap the maximum benefit from the HGP, human DNA sequence should be freely available in the public domain. The NIH Ad Hoc Program Advisory Committee on Complex Genomes stated that "Distribution of and free access to the databases (containing the sequence data) must be fully encouraged. Thus, the data must be in the public domain, and the redistribution of the data should remain free of royalties."[3] Similarly, the National Research Council stated: "... access to all sequences and material generated by these publicly funded projects should and even must be made freely available ..."[2]. Most recently, an international group of scientists, from both the public and private sectors, who are already involved in genomic DNA sequencing, passed a unanimous resolution that "all human genomic DNA sequence information, generated by centers funded for large-scale human sequencing, should be freely available and in the public domain in order to encourage research and development and to maximize its benefit to society"[4].

There are very strong scientific arguments that human genomic DNA sequence should be freely available and in the public domain:

• The human genomic DNA sequence is unique. Although there are many other types of information that contribute to the understanding of human biology, e.g., DNA sequence of model organism genomes, in the end, the only source of definitive information about the human is the human sequence.
  
  
• The human genomic DNA sequence is a vast resource. It contains a very large number of genes and an enormous amount of additional biological information. It is anticipated that the sequence resource will be the basis for many useful inventions and patentable products. It will take many researchers years to find and characterize all of the genes and other functional elements within the sequence and to use that information to develop products and other approaches that will improve the health of the American people.
  
  
• The human genome is a bounded resource. Once the genome has been sequenced, few or no opportunities will exist for discovery of new information that will not make reference to, or be dependent on, that first sequence. Thus, it is important to ensure maximum access of a large number of parties to the initial genomic DNA sequence as it is generated, to provide a broad opportunity for development of new products.

Policy

It is therefore NHGRI s intent that human genomic DNA sequence data, generated by the projects funded under RFA HG-95-005, should be released as rapidly as possible and placed in the public domain where it will be freely available. In order to implement this policy, NHGRI will require that grantees under RFA HG-95-005 adopt a policy of rapid release of data to public databases. This policy will be made a condition of the award.

In NHGRI s opinion, raw human genomic DNA sequence, in the absence of additional demonstrated biological information, lacks demonstrated specific utility and therefore is an inappropriate material for patent filing. NIH is concerned that patent applications on large blocks of primary human genomic DNA sequence could have a chilling effect on the development of future inventions of useful products. Companies are not likely to pursue projects where they believe it is unlikely that effective patent protection will be available. Patents on large blocks of primary sequence will make it difficult to protect the fruit of subsequent inventions resulting from real creative effort. However, according to the Bayh-Dole Act, the grantees have the right to elect to retain title to subject inventions and are free to choose to apply for patents should additional biological experiments reveal convincing evidence for utility. The grantees are reminded that the grantee institution is required to disclose each subject invention to the Federal Agency providing research funds within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. NHGRI will monitor grantee activity in this area to learn whether or not attempts are being made to patent large blocks of primary human genomic DNA sequence.

During this pilot period, NHGRI will be soliciting opinions and collecting evidence from the broad scientific and commercial sectors to allow an evaluation of whether the approach described above is sufficient to ensure that sequence generated by these grants is maximally useful to the research and commercial sectors. If not, NIH will consider a determination of exceptional circumstance to restrict or eliminate the right of parties, under future grants, to elect to retain title.

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Last Reviewed: August 15, 2008