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26 Cap. U. L. Rev. 893 (1997)
Patent Law and Human Genomics

handle is hein.journals/capulr26 and id is 903 raw text is: PATENT LAW AND HUMAN GENOMICS INTRODUCTION ................................................................ 1 I. HUMAN MOLECULAR GENETICS AND BIOTECHNOLOGY .................. 3 A. Basic Molecular Biology Concepts .............................. 3 B. The Genetic Basis for Disease ................................... 4 C. Molecular Medicine and Gene Therapy ........................ 4 D . Biotechnology ..................................................... 5 II. PUBLICLY FUNDED SEQUENCING: THE HUMAN GENOME PROJECT..... 6 A. The Human Genome Organization (HUGO) Statement on D NA Patents ....................................................... 7 III. PRIVATE SEQUENCING: THE GENOMICS INDUSTRY ...................... 8 IV. PATENT LAW AND DNA SEQUENCES ................................... 9 A . Introduction ........................................................ 9 B. Statutory Subject Matter ............................................. 10 C . U tility ................................................................... 11 D . N ovelty ............................................................. 13 E . O bviousness .......................................................... 14 F. Disclosure / Enablement ......................................... 16 V. THE IMPLICATIONS OF GENE PATENTS ...................................... 18 A. The Database Scramble .......................................... 19 B. Litigation Resulting from Gene Patents ....................... 20 C. A Possible Solution ............................................... 20 CONCLUSION .............................................. 21 INTRODUCTION* Genetics is the fundamental biological science, for without genes there is no life. Thus afull understanding of any biological process can be achieved only when there has been a detailed analysis of gene structure and function.' This quote from a genetic engineering textbook presents a clear statement of the profound importance of understanding the genetic composition of human beings. If the human race is to ever completely comprehend the nature of its own bioloy, and overcome the limitations inherent therein, the human genome must be characterized and Copyright © 1997, Courtney J. Miller. * The author thanks Alain Vertes, Ph.D. and Ken Denich, Ph.D. at Battelle Memorial Institute for their comments, criticism, and encouragement. R. W. OLD & S. B. PRIMROSE, PRINCIPLES OF GENE MANIPULATION: AN INTRODUCTION TO GENETIC ENGINEERING 369 (5th ed. 1994). 2 A genome is defined as [T]he complete genetic content of an organism. SUNIL (continued)