Library Catalogue
Measures to prevent evergreening of patents : a comparative analysis
Anuradha Prasad
Measures to prevent evergreening of patents : a comparative analysis - BangaloreBangalore NLSIU 2014 - 97 p. ; 25 cm.
TABLE OF CONTENTS CERTIFICATE ; DECLARATION ; ACKNOWLEDGEMENT ; LIST OF ABBREVIATIONS ; RESEARCH METHODOLOGY ; CHAPTER ONE: INTRODUCTION ; I. MEANING OF THE TERM EVERGREENING ; Examples of Evergreening; II. THE CONCEPT OF INCREMENTAL INNOVATIONI MINOR VARIATION ; III. EFFECTS OF EVERGREENING ; A. THE BRANDED DRUG COMPANY; B. GENERIC DRUG COMPANIES; C. THE CONSUMER; IV. IMPACT OF EVERGREENING ON SOCIAL WELFARE AND POLICY IMPLICATIONS ; Evergeening Threatens Access to Affordable Medicines; CHAPTER TWO: TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ; I. ADVENT OF TRIPS AND CHANGES IN PATENTING IN PHARMACEUTICAL SECTOR; II. TRIPS AND PUBLIC HEAL THFLEXIBILITIES UNDER TRIPS ; A. EXEMPTIONS FROM GRANT OF PATENTS; 1. Principle of good faith; 2. Strict versus liberal patentability standards; B. EXCEPTIONS TO EXCLUSIVE RIGHTS; 1. Early working; Bolar provision as a tool for generic entry; Case analysis; 2. Parallel imports; 3. Research and experimental use; C. COMPULSORY LICENSE AND GOVERNMENT USE; III. THE UNIFORMITY ISSUE UNDER TRIPS ; A. UNIFORMITY WITH RESPECT TO NON-OBVIOUSNESS CRITERION; B. SCOPE OF PATENTABILITY IN THE LIGHT OF THE OBJECTIVES UNDER TRIPS; 1. Art. 7 and 8 cannot derogate the specific mandate of Art. 27; 2. Protection of the rights of the patentee is not the sale concern of TRIPS; IV. IMPLEMENTATION OF TRIPS FLEXIBILITIES ; A. PROCEDURAL SAFEGUARDS; B. POLICY CONSTRAINTS; C. INSTITUTIONAL CONSTRAINTS; CHAPTER THREE: STRATEGIES FOR OBTAINING PATENTS IN PHARMACEUTICAL INDUSTRY ; I. RATIONALE FOR PHARMACEUTICAL COMPANIES TO ENGAGE IN EVERGREENING STRATEGIES; A. EFFECTIVE MARKET EXCLUSIVITY; B. BRANDED VERSUS GENERIC DRUGS; II. EVERGREENING STRATEGIES ; A. DELAY THE LAUNCH OF GENERIC PRODUCTSI 30 MONTH PERIOD OF STAY PROVISION; The case of Bristol-Myers Squibb(BMS) and Taxolc; B. 180 DAYS PERIOD OF MARKET EXCLUSIVITY; 1. Response of the generics; 2. "Failure to market" forfeiture provision; C. AGGRESSIVE LITIGATION; D. STOCKPILE/LINE EXTENSION/PATENT THICKET; E. SECONDARY PATENTS/ ME-TOO DRUGS; The case of Pfizer and Viagra; F. FRANCHISE EXTENSION TO SUCCESSOR DRUGS; The case of AstraZeneca and Prilosec; G. ROLE OF TRADEMARKS IN EVERGREENING; H. PHARMACOGENOMICS; CHAPTER FOUR: PATENT LINKAGE AND DATA EXCLUSIVITY ; I. LINKAGE FORM OF EVERGREENING ; A. LINKAGE PROVISIONS IN THE FREE TRADE AGREEMENTS; B. IMPACT OF PATENT LINKAGE ON GENERIC DRUG; MANUFACTURERS; C. US AND EU POSITION; D. PATENT LINKAGE IN OTHER DEVELOPED COUNTRIES; E. IMPACT OF PATENT LINKAGE IN DEVELOPING COUNTRIES; Case analysis; II. DATA EXCLUSIVITY ; A. TRIPS AND DATA EXCLUSIVITY; 1. Data exclusivity and fiexibilities under TRIPS; 2. Interpretation of unfair commercial use; B. IMPACT OF DATA EXCLUSIVITY ON PRICES AND AVAILABILITY OF GENERIC MEDICINES; 1. Data exclusivity applies regardless of the patentability of a medicine; 2. Delays the onset of generics; 3. Monopoly beyond the patent term; 4. Huge costs for generics; C. INDIAN POSITION; CHAPTER FIVE: FRAMEWORK UNDER THE PATENT LAW TO PREVENT EVERGREENING ; I. PATENTABILITY OF A DRUG ; A. NEW DRUG vis-A-vIS IMPROVEMENTS; B. DOUBLE PATENTING; C. MINOR VARIATIONS; II. SCOPE OF PATENTABILITY ; A. NOVELTY; B. INDUSTRIAL APPLICATION; C. INVENTIVE STEP/NON OBVIOUSNESS; 1. Economic significance as criteria for inventive step; 2. US position on non obviousness; 3. Derivatives and combinations of a drug; 4. Threshold for inventive step; III. NEW USES AND KNOWN FORMS OF EXISTING DRUGS ; IV. LAX VERSUS STRICT PATENTABILITY STANDARDS ; V. PRE AND POST GRANT OPPOSITION ; A. IMPORTANCE OF PATENT OPPOSITION PROCEEDINGS; B. INTERNATIONAL POSITION; C. INDIAN POSITION; D. INVALIDATION OF PATENTS; VI. ROLE OF PATENT OFFICES TO PREVENT EVERGREENING ; A. SHORTCOMINGS OF THE PATENT OFFICES; B. LAX RULES ON PATENTABILITY AND THE PATENT EXAMINATION PROCESS; CHAPTER SIX: SEC. 3(0) OF THE INDIAN PATENT ACT, 1970; TO PREVENT EVERGREENING ; I. EVOLUTION OF SEC. 3(0) ; II. COMPATIBILITY OF SEC. 3(0) WITH TRIPS ; A. ELEMENT OF SINGULARITY IN THE INDIAN PATENT LAW; B. SEC. 3(0) IMPOSES A STRINGENT PATENTABILITY STANDARD; C. SEC. 3(0) MAY BE DISCRIMINATORY AS TO THE FIELD OF TECHNOLOGY III. THE FAMOUS NOVARTIS CASE ; A. THE PATENT OFFICE'S DECISION ON THE PATENTABILITY OF ·GLIVEC; B. THE CONSTITUTIONALITY OF SECTION 3(0); 1. Violated the fundamental right to equality; 2. Structure of Sec. 3(d) vested patent office with unfettered discretion; C. SEC. 3(D)'S COMPLIANCE WITH TRIPS; IV. AN ANALYSIS OF SEC. 3(0) ; A. PATENT ELIGIBILITY VERSUS PATENTABILITY STANDARD; 1. Patent eligibility; 2. Patentability Criteria; B. DERIVATIVE; C. KNOWN SUBSTANCE; D. INTERPRETING THE EXPLANATION; E. "NEW USE" ISSUES; F. DISCOVERY VERSUS INVENTION; G. STANDARD OF PROOF; H. INTERPRETING "SIGNIFICANCE"; I. INTERPRETING EFFICACY; 1. An expansive interpretation; 2. The reguirement of motivation; 3. Drug regulatory law or patent law; 4. Patent examiner to determine increased efficacy; 5. Balance adjuster; V. POWER CONFERRED TO THE CONTROLLER; A. TECHNICAL EXPERTISE OF THE CONTROLLER; B. UNIFORMITY ISSUE UNDER SEC. 3(D); c. PATENT OFFICE BOUND BY DEFINITION OF EFFICACY; VI. SEC. 3(0) AS MODEL LEGISLATION FOR OTHER NATIONS ; CHAPTER SEVEN: CONCLUSION ; BIBLIOGRAPHY/REFERENCES.
Measures to prevent evergreening of patents : a comparative analysis - BangaloreBangalore NLSIU 2014 - 97 p. ; 25 cm.
TABLE OF CONTENTS CERTIFICATE ; DECLARATION ; ACKNOWLEDGEMENT ; LIST OF ABBREVIATIONS ; RESEARCH METHODOLOGY ; CHAPTER ONE: INTRODUCTION ; I. MEANING OF THE TERM EVERGREENING ; Examples of Evergreening; II. THE CONCEPT OF INCREMENTAL INNOVATIONI MINOR VARIATION ; III. EFFECTS OF EVERGREENING ; A. THE BRANDED DRUG COMPANY; B. GENERIC DRUG COMPANIES; C. THE CONSUMER; IV. IMPACT OF EVERGREENING ON SOCIAL WELFARE AND POLICY IMPLICATIONS ; Evergeening Threatens Access to Affordable Medicines; CHAPTER TWO: TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ; I. ADVENT OF TRIPS AND CHANGES IN PATENTING IN PHARMACEUTICAL SECTOR; II. TRIPS AND PUBLIC HEAL THFLEXIBILITIES UNDER TRIPS ; A. EXEMPTIONS FROM GRANT OF PATENTS; 1. Principle of good faith; 2. Strict versus liberal patentability standards; B. EXCEPTIONS TO EXCLUSIVE RIGHTS; 1. Early working; Bolar provision as a tool for generic entry; Case analysis; 2. Parallel imports; 3. Research and experimental use; C. COMPULSORY LICENSE AND GOVERNMENT USE; III. THE UNIFORMITY ISSUE UNDER TRIPS ; A. UNIFORMITY WITH RESPECT TO NON-OBVIOUSNESS CRITERION; B. SCOPE OF PATENTABILITY IN THE LIGHT OF THE OBJECTIVES UNDER TRIPS; 1. Art. 7 and 8 cannot derogate the specific mandate of Art. 27; 2. Protection of the rights of the patentee is not the sale concern of TRIPS; IV. IMPLEMENTATION OF TRIPS FLEXIBILITIES ; A. PROCEDURAL SAFEGUARDS; B. POLICY CONSTRAINTS; C. INSTITUTIONAL CONSTRAINTS; CHAPTER THREE: STRATEGIES FOR OBTAINING PATENTS IN PHARMACEUTICAL INDUSTRY ; I. RATIONALE FOR PHARMACEUTICAL COMPANIES TO ENGAGE IN EVERGREENING STRATEGIES; A. EFFECTIVE MARKET EXCLUSIVITY; B. BRANDED VERSUS GENERIC DRUGS; II. EVERGREENING STRATEGIES ; A. DELAY THE LAUNCH OF GENERIC PRODUCTSI 30 MONTH PERIOD OF STAY PROVISION; The case of Bristol-Myers Squibb(BMS) and Taxolc; B. 180 DAYS PERIOD OF MARKET EXCLUSIVITY; 1. Response of the generics; 2. "Failure to market" forfeiture provision; C. AGGRESSIVE LITIGATION; D. STOCKPILE/LINE EXTENSION/PATENT THICKET; E. SECONDARY PATENTS/ ME-TOO DRUGS; The case of Pfizer and Viagra; F. FRANCHISE EXTENSION TO SUCCESSOR DRUGS; The case of AstraZeneca and Prilosec; G. ROLE OF TRADEMARKS IN EVERGREENING; H. PHARMACOGENOMICS; CHAPTER FOUR: PATENT LINKAGE AND DATA EXCLUSIVITY ; I. LINKAGE FORM OF EVERGREENING ; A. LINKAGE PROVISIONS IN THE FREE TRADE AGREEMENTS; B. IMPACT OF PATENT LINKAGE ON GENERIC DRUG; MANUFACTURERS; C. US AND EU POSITION; D. PATENT LINKAGE IN OTHER DEVELOPED COUNTRIES; E. IMPACT OF PATENT LINKAGE IN DEVELOPING COUNTRIES; Case analysis; II. DATA EXCLUSIVITY ; A. TRIPS AND DATA EXCLUSIVITY; 1. Data exclusivity and fiexibilities under TRIPS; 2. Interpretation of unfair commercial use; B. IMPACT OF DATA EXCLUSIVITY ON PRICES AND AVAILABILITY OF GENERIC MEDICINES; 1. Data exclusivity applies regardless of the patentability of a medicine; 2. Delays the onset of generics; 3. Monopoly beyond the patent term; 4. Huge costs for generics; C. INDIAN POSITION; CHAPTER FIVE: FRAMEWORK UNDER THE PATENT LAW TO PREVENT EVERGREENING ; I. PATENTABILITY OF A DRUG ; A. NEW DRUG vis-A-vIS IMPROVEMENTS; B. DOUBLE PATENTING; C. MINOR VARIATIONS; II. SCOPE OF PATENTABILITY ; A. NOVELTY; B. INDUSTRIAL APPLICATION; C. INVENTIVE STEP/NON OBVIOUSNESS; 1. Economic significance as criteria for inventive step; 2. US position on non obviousness; 3. Derivatives and combinations of a drug; 4. Threshold for inventive step; III. NEW USES AND KNOWN FORMS OF EXISTING DRUGS ; IV. LAX VERSUS STRICT PATENTABILITY STANDARDS ; V. PRE AND POST GRANT OPPOSITION ; A. IMPORTANCE OF PATENT OPPOSITION PROCEEDINGS; B. INTERNATIONAL POSITION; C. INDIAN POSITION; D. INVALIDATION OF PATENTS; VI. ROLE OF PATENT OFFICES TO PREVENT EVERGREENING ; A. SHORTCOMINGS OF THE PATENT OFFICES; B. LAX RULES ON PATENTABILITY AND THE PATENT EXAMINATION PROCESS; CHAPTER SIX: SEC. 3(0) OF THE INDIAN PATENT ACT, 1970; TO PREVENT EVERGREENING ; I. EVOLUTION OF SEC. 3(0) ; II. COMPATIBILITY OF SEC. 3(0) WITH TRIPS ; A. ELEMENT OF SINGULARITY IN THE INDIAN PATENT LAW; B. SEC. 3(0) IMPOSES A STRINGENT PATENTABILITY STANDARD; C. SEC. 3(0) MAY BE DISCRIMINATORY AS TO THE FIELD OF TECHNOLOGY III. THE FAMOUS NOVARTIS CASE ; A. THE PATENT OFFICE'S DECISION ON THE PATENTABILITY OF ·GLIVEC; B. THE CONSTITUTIONALITY OF SECTION 3(0); 1. Violated the fundamental right to equality; 2. Structure of Sec. 3(d) vested patent office with unfettered discretion; C. SEC. 3(D)'S COMPLIANCE WITH TRIPS; IV. AN ANALYSIS OF SEC. 3(0) ; A. PATENT ELIGIBILITY VERSUS PATENTABILITY STANDARD; 1. Patent eligibility; 2. Patentability Criteria; B. DERIVATIVE; C. KNOWN SUBSTANCE; D. INTERPRETING THE EXPLANATION; E. "NEW USE" ISSUES; F. DISCOVERY VERSUS INVENTION; G. STANDARD OF PROOF; H. INTERPRETING "SIGNIFICANCE"; I. INTERPRETING EFFICACY; 1. An expansive interpretation; 2. The reguirement of motivation; 3. Drug regulatory law or patent law; 4. Patent examiner to determine increased efficacy; 5. Balance adjuster; V. POWER CONFERRED TO THE CONTROLLER; A. TECHNICAL EXPERTISE OF THE CONTROLLER; B. UNIFORMITY ISSUE UNDER SEC. 3(D); c. PATENT OFFICE BOUND BY DEFINITION OF EFFICACY; VI. SEC. 3(0) AS MODEL LEGISLATION FOR OTHER NATIONS ; CHAPTER SEVEN: CONCLUSION ; BIBLIOGRAPHY/REFERENCES.