Intellectual Property Rights and the Human Genome

Abstract

Advances in genetics and molecular biology over the past 20 years have brought intellectual property issues to the fore in the life sciences. During the 1970s, patent applications on biological molecules with potential as new products, biologically-based processes, and genetically modified organisms were made on an increasingly large scale by a vibrant and growing U.S. biotechnology industry and by U.S. academic scientists, particularly those who were active in developing academic-industry links. Today, the use of intellectual property in the life sciences and some specialised biotechnology areas has become so well established that academic public sector scientists and industry researchers alike file patent applications on nucleic acids (DNA and RNA), proteins, cell lines, genetically modified micro-organisms, transgenic animals and plants. Nevertheless, the development of intellectual property rights for the life sciences has been the subject of wide and intense debate. Nowhere has this been more evident than in the human genome project. Genomics, the analysis of structure of function in human, plant, animal and microbial genomes is one area of the life sciences where patenting is likely to be particularly intensive in the next decade. In this chapter, current issues raised by the application of intellectual property rights to research and development in human genome analysis and their implications for public policy are discussed.