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55 U. Pitt. L. Rev. 633 (1993-1994)
A Technology Policy Perspective on the NIH Gene Patenting Controversy

handle is hein.journals/upitt55 and id is 643 raw text is: A TECHNOLOGY POLICY PERSPECTIVE ON THE NIH GENE PATENTING CONTROVERSY Rebecca S. Eisenberg* I. INTRODUCTION The Human Genome Project provides government funds for the generation of vast amounts of information in the hope that the informa- tion will ultimately be used to develop new products and processes for the diagnosis and treatment of human disease.' Much of this informa- tion is generated in government and university laboratories that cannot undertake the downstream research and development necessary to translate basic research discoveries into commercial products. Technol- ogy transfer to the private sector is thus a prerequisite to the develop- ment of genome-related products, but achieving technology transfer in such a project is a matter of some complexity. Some of the difficulties involved are suggested by the reaction of industry trade groups to the filing of patent applications by the Na- tional Institutes of Health (NIH) on thousands of partial complemen- tary DNA (cDNA) sequences of unknown function that were identified in government laboratories.2 The research that led to the controversial patent applications consisted of taking randomly selected copies of genes that were being expressed in human brain tissue and finding the DNA sequence for small portions of those genes, without knowing what * Professor of Law, University of Michigan Law School. A.B. Stanford University (1975); J.D. University of California at Berkeley (Boalt Hall) (1979). 1. The Human Genome Project is a jointly sponsored effort of the National Institutes of Health and the Department of Energy to create a detailed map of human DNA, which would identify the location and nucleotide sequence of all human genes and the intergenic regions that connect them. This information has potentially enormous benefits for the understanding and treat- ment of human disease, including the development of new methods of diagnosing and treating diseases that have a genetic component, such as hereditary forms of cancer, Alzheimer's disease, manic-depressive illness, Huntington's disease and cystic fibrosis. See NATIONAL RES COUNCIL, MAPPING AND SEQUENCING THE HUMAN GENOME (1988); US. CONG. OFFICE OF TECH ASSESS- MENT. MAPPING OUR GENES-THE GENOME PROJECTS How BIG, How FAST? (1988). 2. See Reid G. Adler, Genome Research: Fulfilling the Public's Expectations for Knowl- edge and Commercialization, 257 SCIENCE 908, 910 (1992); Rebecca S. Eisenberg, Genes, Pat- ents, and Product Development, 257 SCIENCE 903 (1992); Bernadine Healy, Special Report on Gene Patenting, 327 NEw ENG. J. MED. 664, 666-67 (1992); Thomas D. Kiley, Patents on Ran- dom Complementary DNA Fragments?, 257 SCIENCE 915 (1992).

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