Table Of Contents  I. Abbreviations II. Introduction III. Why Qualify Intellectual Property?        A. Pancakes and Global Intellectual Property Waves        B. Product Clusters: Path of Least Resistance to Patent           Portfolios        C. Summary IV. Study Objectives V. Methods        A. Drug Approval Nomenclature and Classification        B. Innovation Index        C. Examples of LOI Compound-Indication           Classifications        D. Curve Fitting        E. Data Analysis VI. RESULTS        A. Presentation of Data        B. Total Approval Cohort        C. MP Approval Cohort        D. MP Patenting Cohort        E. MP Chemical Cohort        F. Class Trends Across Indicators VII. Discussion        A. Interpretation of the Data           1. Drug Approval           2. Drug Patenting           3. Drug Chemical Components           4. Class Trends Across Indicators           5. Limitations        B. Interpretation of the Model           1. Objective-Subjective Considerations           2. Intellectual Property Law Considerations        C. Relevance to Pharmaceutical Law and Policy           1. Patent and Innovation Policy           2. Listing of Patents on the Patent Register           3. Cluster-Based Drug Development           4. Impact on Competition VIII. SUMMARY & CONCLUSIONS 

I. ABBREVIATIONS

ANDS Abbreviated New Drug Submission

ER Expedited Review

FIC First in Class

NAS New Active Substance

NCE New Chemical Entity

NDS New Drug Submission

NDS NAS NDS drug containing a NAS

NDS ER NDS drug undergoing ER

NDS FIC FIC drug approved via NDS route

NDS Me Too Me Too drug approved via NDS route

NDS MI Most Innovative NDS Drug

NOC Notice of Compliance

NOC/c Notice of Compliance with Conditions

PR Priority Review

SANDS Supplemental Abbreviated New Drug Submission

SNDS Supplemental New Drug Submission

SNDS ER SNDS drug undergoing ER

SNDS FIC FIC drug approved via SNDS route

SNDS Me Too Me Too drug approved via SNDS route

II. INTRODUCTION

Governments around the world have become uniformly locked in to the political mandate of innovation, both in developed and developing nations. It is a race no one wants to lose. Yet, despite the non-rival nature of knowledge, (1) it is one few will win. Innovation is widely accepted to be a fundamental gateway to national and global productivity and prosperity. (2) Nowhere is this truer than in the fields of science and technology, particularly in the life sciences. (3) The argument in favor of patenting in the pharmaceutical industry has been made consistently and with vigor for over a half-century. (4) The pharmaceutical industry claims that its research and development (R&D) activities are responsible for most new and innovative medicines. (5) Indeed, a major justification for high and increasing drug expenditures is that such profits are necessary to underpin the development of new and innovative drugs. (6)

To date, innovation is measured using primarily quantitative methods. (7) Patents are usually used as the prime measure. (8) Methods most often reported include counting patents, patent citations, prior art citations and related litigation outcomes. (9) These measures are used extensively in prominent domestic, regional and global reports focused on productivity and prosperity. (10) indeed, much of what governments understand about innovation is currently shaped by measurements of patenting activity. For example, patenting licensing, litigation, and prior art citation data can be useful as indicators of how general knowledge flows within and between different industries, (11) and has helped to shape priority areas for government investment, (12) including several sectors within the life sciences rubric. (13) Citation counting has demonstrated differences between public and private patentees in the medical research and product development sector, leading some to conclude that non-profit patents, such as those to universities, are valuable to the ultimate commercialization of medicines. …