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

摘要

Most observers predict significant health-related gains from genomicsudresearch. Policy and legal decisions made by government institutions,udthe courts and legislatures have the potential to make a significantudimpact on both the quantity and quality of effective and innovativeudhealthcare-related products ultimately derived from the vibrant genomicsudresearch enterprise. In particular, the careful management of theudintellectual property (IP) aspects of this promising area of research willudbe necessary to maximise scientific progress, provide appropriateudincentives for investment, and ultimately ensure optimal public benefit.udIt is the mission of the US National Institutes of Health (NIH), which isudcomprised of 27 individual institutes and is an agency of the USudDepartment of Health and Human Services, to facilitate the translationudof basic biomedical research discoveries into useful healthcare servicesudand products. Within the NIH, the National Human Genome ResearchudInstitute (NHGRI) is the agency’s lead entity for advancing humanudhealth through genetic research.Through its stewardship of an array of infrastructure and researchudprojects, including several innovative public-private consortia efforts, theudNHGRI seeks to contribute to the genomic tools, data and knowledgeudbases. In general, I believe that scientific progress in this still young fieldudwill be best served by early, open and continuing access to: i)udcomprehensive, high-quality data sets containing basic biological andudbiochemical data; and ii) critical biological materials such as animaludmodels and genes. Data such as the complete nucleotide sequence ofudmany different organisms’ genomes, information on genetic variationudwithin and among populations, and results on how gene expression isudregulated at the cellular and molecular level are often referred to as ‘precompetitive’udinformation, and in my view should be made rapidlyudavailable to all, without restrictions on use. Adherence by data andudresource producers and users to this simple strategy should ensure thatudindustry and academic researchers will be able to build upon this strongudfoundation.udAt the NIH we are expected to support basic scientific discovery whilstudsimultaneously facilitating the appropriate commercial research anduddevelopment of the results of our formidable research programs. Audsizeable number of end users for these resource projects are employedudwith private sector companies. For this constituency the termsudgoverning the data use, data release, the sharing and distribution ofudresearch resources and intellectual property rights of derivativeudinventions are of particular importance. Policies that limit companies’udability to file patent applications or licence downstream uses could endudup having an unintended inhibitory effect on the development ofudbiomedical products. Government policies need to balance theudimportant dual goals of continuing to rapidly place huge amounts of dataudin the public domain and encouraging restriction-free sharing ofudgenomic tools, whilst also ensuring that more applied inventions,udnotably those closer to being an actual product, can be patented. USudtaxpayers, and especially patients, would like the government toudappropriately foster the commercialisation of promising inventionsudderived from use of the data and reagents generated by these efforts.udCurrently, the NHGRI is actively involved in the development andudvetting of policy options aimed at ensuring that genomic tools, resourcesudand databases of genomic information are used in a manner thatudpromotes scientific research and the practice of medicine. Relevant policies implemented by NIH-supported public privateudconsortia efforts such the International Human Genome SequencingudConsortium (IHGSC),2 the Trans-NIH Mouse Initiative,3 theudMammalian Gene Collection (MGC)4 and the International HaplotypeudMap Project (HapMap)5 are specifically covered in this review.