Final Report to the Commonwealth Department of Industry, Tourism and Resources Review of Pharmaceutical Patent Extension and Springboarding Provisions in Various Jurisdictions INTELLECTUAL PROPERTY RESEARCH INSTITUTE OF AUSTRALIA (IPRIA) Andrew F. Christie, Saba Elkman and Melanie J. Howlett 6 November 2002 Review of Pharmaceutical Patent Extension and Springboarding Provisions CONFIDENTIAL 2 Table of Contents EXECUTIVE SUMMARY .........................................................................................5 1. REVIEW OF PATENT EXTENSIONS ..............................................................10 1.1 INTRODUCTION ...................................................................................................10 1.2 UNITED STATES ..................................................................................................10 1.2.1 Laws and Regulations.................................................................................10 1.2.2 Interpretation ..............................................................................................13 1.2.3 Proposals for Reform..................................................................................13 1.2.4 Patent Extensions Pursuant to 35 USC § 154 ............................................14 1.3 CANADA .............................................................................................................15 1.3.1 Laws and Regulations.................................................................................15 1.3.2 Proposals for Reform..................................................................................15 1.4 EUROPEAN UNION...............................................................................................15 1.4.1 Laws and Regulation...................................................................................15 1.4.2 Interpretation ..............................................................................................18 1.4.3 Proposals for Reform..................................................................................18 1.5 AUSTRALIA .........................................................................................................18 1.5.1 Laws and Regulations.................................................................................18 1.5.2 Interpretation ..............................................................................................23 1.6 COMPARISON OF US, EU AND AUSTRALIAN EXTENSION PROVISIONS................25 1.6.1 Scope of Extension Provisions....................................................................25 1.6.2 Requirements for an Extension of Term......................................................26 1.6.3 Length of Patent Extensions........................................................................26 1.6.4 Maximum Effective Patent Life...................................................................28 1.7 SUMMARY...........................................................................................................29 1.7.1 Tabular Summary........................................................................................29 2. EMPIRICAL DATA ON PATENT TERM.........................................................30 2.1 INTRODUCTION ...................................................................................................30 2.2 DATA ON PATENT EXPIRY...................................................................................30 2.2.1 Methodology ...............................................................................................31 2.2.2 Empirical Data on Patent Expiry Dates - Table 1......................................33 2.2.3 Difference in Expiry Dates..........................................................................35 2.2.4 Conclusions.................................................................................................36 2.3 DATA ON PATENT EXTENSION ............................................................................36 2.3.1 Methodology ...............................................................................................36 2.3.2 Empirical Data on Length of Patent Extension - Table 2..........................38 2.3.3 Conclusions.................................................................................................40 2.4 DATA ON THE CHANGE IN THE EXTENSION LENGTH OVER TIME ........................40 Review of Pharmaceutical Patent Extension and Springboarding Provisions CONFIDENTIAL 3 2.4.1 Methodology ...............................................................................................40 2.4.2 Data on the Change in Patent Extension Length over Time - Table 3 .......41 2.4.3 Conclusions.................................................................................................42 2.5 FILING AND GRANT DATES .................................................................................42 2.5.1 Methodology ...............................................................................................43 2.5.2 Empirical Data on Filing and Grant Dates - Table 4 ................................44 2.5.3 Summary of Differences in Filing and Grant Dates - Table 5....................46 2.5.4 Conclusions.................................................................................................46 2.6 DATA ON THE PERIOD OF REGULATORY REVIEW................................................47 2.6.1 United States ...............................................................................................47 2.6.2 European Union..........................................................................................48 2.6.3 Australia......................................................................................................48 2.6.4 Comparison.................................................................................................49 2.7 REASONS FOR DIFFERENCES IN EXPIRY DATES BETWEEN AU AND US PATENTS50 2.7.1 Introduction.................................................................................................50 2.7.2 Structural Reasons for Current Differences in Expiry Dates .....................50 2.7.3 Practical Reasons for Current Differences in Expiry Dates ......................56 2.7.4 Transitional Reasons for Current Differences in Expiry Dates..................57 2.7.5 Future Prospects for Closing the Gap Between Patent Expiry Dates........60 3. OTHER METHODS FOR EXTENDING MARKET EXCLUSIVITY ...........63 3.1 INTRODUCTION ...................................................................................................63 3.2 NON-LEGISLATIVE METHODS .............................................................................63 3.3 LEGISLATIVE METHODS......................................................................................64 3.3.1 US................................................................................................................64 3.3.2 Canada........................................................................................................70 3.3.3 European Union..........................................................................................72 3.3.4 Australia......................................................................................................72 4. REVIEW OF SPRINGBOARDING ....................................................................74 4.1. INTRODUCTION ..................................................................................................74 4.2. UNITED STATES .................................................................................................74 4.2.1 Laws and Regulations.................................................................................74 4.2.2 Interpretation ..............................................................................................75 4.2.3 Proposals For Reform.................................................................................75 4.3. CANADA ............................................................................................................75 4.3.1 Laws and Regulations.................................................................................75 4.3.2 Interpretation ..............................................................................................76 4.3.3 Proposals For Reform.................................................................................77 4.4. EUROPEAN UNION..............................................................................................78 4.4.1 Laws and Regulations.................................................................................78 4.4.2 Proposals For Reform.................................................................................79 Review of Pharmaceutical Patent Extension and Springboarding Provisions CONFIDENTIAL 4 4.5. AUSTRALIA ........................................................................................................79 4.5.1 Laws and Regulations.................................................................................79 4.5.2 Interpretation ..............................................................................................81 4.5.3 Proposals For Reform.................................................................................81 4.6. OTHER JURISDICTIONS .......................................................................................81 4.6.1 Israel ...........................................................................................................81