Caught in the Middle: Reducing the Uncertainty Created by the FDA and the Patent System for Genetic Diagnostic Test Makers By Sharonmoyee Goswami* A pdf version of this article may be downloaded here. Introduction I. Current Regulatory Framework for Genetic Diagnostic Tests and the Dangers of Increased Regulation A. Institutional Frameworks at the FDA B. FDA Shift in Regulating Genetic Diagnostic Tests C. The Three Classes of Devices for FDA Approval D. Choice of Classification Delays Market Entry and Can Be Uncertain E. Historical Expansion of Regulation Has Been Alleviated by Commensurate Expansion in Patent and FDA-Mediated Data Exclusivity II. Why We Need Better Regulation of Genetic Diagnostic Tests A. Molecular Markers That Do Not Correctly Predict the Presence of a Disease Allele B. Mistakes in Genetic Test Interpretation Occur Because of Genetic and Environmental Variation C. Mistakes in Genetic Test Interpretation Occur Because of Unforeseen Interactions between Genes III. Is a Per Se Patentable Subject Matter Rule for Genetic Diagnostic Tests the Solution? A. A Per Se Rule Does Not Fit within the Patentable Subject Matter Framework B. In the Absence of a Per Se Rule, Companies Still Need a Baseline Level of Exclusivity IV. Suggestions for a New Regulatory Regime for Genetic Diagnostic Tests 1. Increase Requirements for Labeling and Genetic Counseling That Keep up with Developing Technology through Monthly Meetings 2. Provide Data-Exclusivity for Class II Tests That Require Additional Clinical Studies 3. Create Mandatory Maximum Times for Class II and Class III Approval Processes or Increase the Scope of Class II Devices to Decrease Overall Approval Times 4. Solicit Complaints Directly from Consumers 5. Require Minimal Regulation of Purely Software-Based Genetic Diagnostic Tests V. Application of Proposed Regulatory Regime to a Challenge for the FDA A. Regulation of Analytical Validity and Classification of the Tests B. Possible Patent Protection and Data Exclusivity Conclusion Continue reading →
