Release Date:  March 17, 1999


National Institute of Allergy and Infectious Diseases


In its support of large-scale pathogen genome sequencing projects, the
National Institute of Allergy and Infectious Diseases (NIAID) seeks to balance
the rights of its grantees with the needs of the research community.  NIAID
recognizes that large-scale genome sequence information is a unique research
resource* and that rapid and unrestricted sharing of microbial genome sequence
data is essential for advancing research on infectious agents responsible for
human disease.  Early release of unfinished sequence has proven useful in
accelerating the pace of experimental discovery.  At the same time, it is also
necessary to give investigators time to verify the accuracy of their data and
to accomplish the goals proposed in their application, which often includes
the assembly and annotation of the sequence data.


Applications for support of pathogen genome sequencing projects should include
a detailed description of the data release plan.  Timely release is strongly
encouraged and should be implemented in consultation with the NIAID program
officer and in recognition of the benefits to the broader research community. 
Release should be accompanied by appropriate information on the reliability of
the data (e.g. level of coverage and extent of assembly, extent of
contamination with vector and other sequences, statistical measures of
accuracy).  At a minimum, it is anticipated that sequence data will be
released within one month after 3X coverage of the genome (or chromosome for
eukaryotic organisms) is achieved. The released data should be provided as
assemblies of equal to, or greater than, one kilobase contigs.  Subsequent
releases of assembled sequences should be provided on a monthly basis.  NIAID
expects that users of the released data will appropriately acknowledge their

Prior to funding, NIAID will review the investigator's proposed data release
plan.  No award will be made until an acceptable plan has been approved and
incorporated into the terms of award.  Because the community standard for
early data release is presently evolving, plans for data release will be re-
assessed at the end of each budget period.

In NIAID's opinion, raw genomic sequence, in the absence of additional
demonstrated biological information, lacks demonstrated utility and therefore
is an inappropriate material for patent filing.  NIH is concerned that patent
applications on large blocks of primary genomic sequence could stifle future
research and the development of future inventions of useful products. 
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 of
utility.  NIH Grantees are reminded that the grantee institution is required
to disclose each subject invention to the NIH within two months after the
inventor discloses it in writing to grantee institution personnel responsible
for patent matters.  NIAID staff will monitor grantee activity in this area to
determine if attempts are being made to patent large blocks of primary genomic

*Public Health Service Policy Relating to Distribution of Unique Research
Resources (NIH Guide, Vol. 25, No. 23, July 12, 1996;

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