NIH Data and Resource Sharing, Data Release and Intellectual Property Policies for Genomics Community Resource Projects

Abstract

Most observers predict significant health-related gains from genomics research. Policy and legal decisions made by government institutions, the courts and legislatures have the potential to make a significant impact on both the quantity and quality of effective and innovative healthcare-related products ultimately derived from the vibrant genomics research enterprise. In particular, the careful management of the intellectual property (IP) aspects of this promising area of research will be necessary to maximise scientific progress, provide appropriate incentives for investment, and ultimately ensure optimal public benefit. It is the mission of the US National Institutes of Health (NIH), which is comprised of 27 individual institutes and is an agency of the US Department of Health and Human Services, to facilitate the translation of basic biomedical research discoveries into useful healthcare services and products. Within the NIH, the National Human Genome Research Institute (NHGRI) is the agency’s lead entity for advancing human health through genetic research.Through its stewardship of an array of infrastructure and research projects, including several innovative public-private consortia efforts, the NHGRI seeks to contribute to the genomic tools, data and knowledge bases. In general, I believe that scientific progress in this still young field will be best served by early, open and continuing access to: i) comprehensive, high-quality data sets containing basic biological and biochemical data; and ii) critical biological materials such as animal models and genes. Data such as the complete nucleotide sequence of many different organisms’ genomes, information on genetic variation within and among populations, and results on how gene expression is regulated at the cellular and molecular level are often referred to as ‘precompetitive’ information, and in my view should be made rapidly available to all, without restrictions on use. Adherence by data and resource producers and users to this simple strategy should ensure that industry and academic researchers will be able to build upon this strong foundation. At the NIH we are expected to support basic scientific discovery whilst simultaneously facilitating the appropriate commercial research and development of the results of our formidable research programs. A sizeable number of end users for these resource projects are employed with private sector companies. For this constituency the terms governing the data use, data release, the sharing and distribution of research resources and intellectual property rights of derivative inventions are of particular importance. Policies that limit companies’ ability to file patent applications or licence downstream uses could end up having an unintended inhibitory effect on the development of biomedical products. Government policies need to balance the important dual goals of continuing to rapidly place huge amounts of data in the public domain and encouraging restriction-free sharing of genomic tools, whilst also ensuring that more applied inventions, notably those closer to being an actual product, can be patented. US taxpayers, and especially patients, would like the government to appropriately foster the commercialisation of promising inventions derived from use of the data and reagents generated by these efforts. Currently, the NHGRI is actively involved in the development and vetting of policy options aimed at ensuring that genomic tools, resources and databases of genomic information are used in a manner that promotes scientific research and the practice of medicine. Relevant policies implemented by NIH-supported public private consortia efforts such the International Human Genome Sequencing Consortium (IHGSC),2 the Trans-NIH Mouse Initiative,3 the Mammalian Gene Collection (MGC)4 and the International Haplotype Map Project (HapMap)5 are specifically covered in this review.