ABSTRACT

Overview of Patent Law Statutes and Guidelines Applied to Genomic Inventions.......................................................................................... 322

General Legal Requirements for Patentability......................................... 324 The Utility Requirement: At What Stage of Discovery Can a Biochemical Be Patented? ............................................................. 326 Requirements of Written Description under 35 U.S.C. Section 112 ............................................................................................... 331

IP Implications for DNA Chips and Microarrays ...............................................334 Nonuniform Application of Evolving Guidelines for Examining Biotechnology Inventions ...................................................... 334 Patenting on Genes as Affecting Diagnostic Research............................ 335 Multiple Patents: Cost Impact on Drug Product Development............... 336 Claims to Subfragments of Cloned DNA with Unique Functional Properties ................................................................................ 336

Other Solutions to Promote Innovation: Free Sharing of SNP Information .............................................................................................. 337 Conclusion ............................................................................................................ 337

Development of the array format for DNA hybridization assays has changed the speed and throughput that researchers can achieve, permitting researchers to study hundreds or thousands of DNA sequences in a single experiment.