Brand Renegades By Jeremy Sheff* A pdf version of this article may be downloaded here. Introduction I. Whence the Renegade? II. The Renegade in Our Midst A. Adoption and Co-Option B. Reality Bites C. Cutting Loose III. The Legal Limits of Social Brands A. Trademark Law’s Expansion B. The Brand Renegade at the Outer Limit C. Drawing a Line Conclusion Continue reading →
Choking the Channel of Public Information: Re-Examination of an Eighteenth-Century Warning about Copyright and Free Speech By Edward L. Carter* A pdf version of this article may be downloaded here. Introduction I. Scholarly Views on Donaldson v. Beckett II. Alexander Donaldson and the Crusade Against Speech Monopoly III. Donaldson v. Beckett Re-Examined A. Day 1: Friday, February 4, 1774 B. Day 2: Monday, February 7, 1774 C. Day 3: Tuesday, February 8, 1774 D. Day 4: Wednesday, February 9, 1774 E. Days 5, 6 and 7: Tuesday, February 15, 1774; Thursday, February 17, 1774; and Monday, February 21, 1774 1. Was There a Common Law Copyright? 2. Was the Common Law Copyright Lost upon Publication? 3. Did the Statute of Anne Supersede the Common Law Copyright? 4. Was There a Perpetual Common Law Copyright That Authors Could Assign to Printers? 5. Did the Statute of Anne Supersede the Perpetual and Assignable Common Law Copyright? F. Day 8: Tuesday, February 22, 1774 Conclusion Appendix—Summary of Data from Westlaw “Journals and Law Reviews” Database on Donaldson v. Beckett Continue reading →
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 →
Ideas and the Public Domain: Revisiting INS v. AP in the Internet Age Andrew Beckerman-Rodau* A pdf version of this article may be downloaded here. Introduction I. Property Rights in Intangibles II. Common Law Misappropriation of an Idea or Information A. The Historical Source of the Misappropriation Doctrine B. An Overview of Contemporary Application of the Misappropriation Doctrine C. Continued Viability of Actions for Misappropriation of an Idea or Information III. Critical Review of the Misappropriation Doctrine A. The Problem with the Property Rationale B. Free Riding C. Ruinous Competition IV. Reliance on Existing Tort and Contract Theories Conclusion Continue reading →
