Realizing two-tiered innovation policy through drug regulation.
INTRODUCTION.............................................................................................. 1221 I. OVERVIEW OF DRUG REGULATION............................................................ 1225 II. PATENT LAW’S DECLINING INFLUENCE ON DRUG INNOVATION POLICY . 1228 A. The Emergence of an Independent Written Description Requirement .................................................................................... 1228 1. Written description and the anatomy of a patent ........................ 1228 2. Written description’s impact on drug patents ............................. 1229 B. The Rise of Patented Research Inputs ............................................... 1232 C. Drug Patenting as Copyright ............................................................ 1234 III. DRUG REGULATION’S GROWING IMPACT ON INNOVATION POLICY........ 1235 A. Explicit Innovation Policy Provisions............................................... 1235 B. Implicitly Remedying the Public Goods Problem ............................. 1236 IV. ADVANTAGES OF TWO-TIERED INNOVATION POLICY............................. 1240 A. Aligning with Patent Law’s Justifications......................................... 1240 B. Decreasing Pressure on the PTO To Determine Utility .................... 1242 C. Focusing Protection Where It Counts ............................................... 1244 1. Focus on a drug’s use ................................................................. 1245 2. Focus on commercialization ....................................................... 1246 CONCLUSION................................................................................................. 1249